A Comparison of Moxifloxacin and Amoxicillin in the Treatment of Community-Acquired Pneumonia in Latin America: Results of a Multicenter Clinical Trial

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"etiqueta" => "a" "identificador" => "affa" ] 1 => array:3 [ "entidad" => "Centro Médico Nacional La Raza, Mexico City, Mexico." "etiqueta" => "b" "identificador" => "affb" ] 2 => array:3 [ "entidad" => "Institut Clínic de Pneumologia i Cirurgia Toràcica, IDIBAPS, Hospital Clínic, Barcelona, Spain." "etiqueta" => "c" "identificador" => "affc" ] 3 => array:3 [ "entidad" => "Hospital General Tijuana, Tijuana, Mexico." "etiqueta" => "d" "identificador" => "affd" ] 4 => array:3 [ "entidad" => "INER, Mexico City, Mexico." "etiqueta" => "e" "identificador" => "affe" ] 5 => array:3 [ "entidad" => "Fundación Arriarán, Santiago de Chile, Chile." "etiqueta" => "f" "identificador" => "afff" ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Moxifloxacino frente a amoxicilina en el tratamiento de la neumonía adquirida en la comunidad en América Latina. Resultados de un ensayo clínico multicéntrico" ] ] "textoCompleto" => "Introduction Community-acquired pneumonia (CAP) is a common infection with high morbidity. The exact incidence of CAP is not known because it is not a reportable disease, but it is estimated that it could range between 1.6 and 13.4 per 1000 people per year.1-4 Since the morbidity and mortality of CAP are high and the disease represents a major cost to health services all over the world, the treatment prescribed should be as effective as possible. The treatment strategies recommended in the guidelines published by different international institutions are, however, controversial and difficult to standardize for all patients and across different geographical areas.5-8 One of the main reasons for modifying the established regimens of empirical therapy is the variation in the susceptibility patterns of the most common pathogens, particularly Streptococcus pneumoniae and Haemophilus influenzae. Relatively few studies have been carried out in Latin America on the etiology of CAP and the patterns of antibiotic susceptibility of its causal agents. In 2 studies carried out in Brazil and Argentina, a high prevalence of atypical pathogens was observed.9,10 It is also worth noting that the scant data available on resistance indicates that the resistance of the pneumococcus to penicillin may be as high as 25%.11It is important to obtain data on the etiology of CAP and the patterns of antibiotic susceptibility across different geographical areas, as well as information concerning the efficacy of new antibiotics in this context. This paper brings together data from hospitals in 5 Latin American countries which participated in an international clinical trial undertaken to evaluate the efficacy and safety of treatment with moxifloxacin in comparison with amoxicillin, both administered for 10 days, in adult patients with suspected pneumococcal CAP. This paper presents details of the pathogens isolated and the patterns of sensitivity to traditional antibiotics.MethodStudy DesignThis was a prospective, multicenter, multinational, controlled, double-blind, randomized study conducted in 82 centers located in 20 countries to compare the efficacy and safety of moxifloxacin and amoxicillin in the treatment of suspected pneumococcal CAP in adult patients. The methodology of this study was recently published elsewhere.12 The present paper describes the pathogens isolated, the patterns of antibiotic sensitivity, and the clinical and microbiological results obtained in the hospitals located in Latin America. The participating countries were Mexico, with 7 hospitals, and Chile, Argentina, Uruguay and Brazil, with 1 each. Patients eligible for inclusion in the study were randomized to receive one of the following treatments during a 10-day period: 400 mg of moxifloxacin (tablets) once a day, or 500 mg of amoxicillin (2 capsules 3 times a day). Patients were either hospitalized or treated as outpatients depending on the criteria of each investigator.This study was conducted with approval from the ethics committees in each of the participating countries. Informed consent was obtained from each patient prior to entry into the study.Study PopulationAdult patients (≥18 years of age) presenting with CAP of suspected pneumococcal origin were enrolled in the study. Patients were classified as having CAP if they presented with fever (rectal temperature >38.5ºC or oral temperature >38.0ºC), radiologic evidence of pneumonia, and at least one of the following signs or symptoms: purulent sputum, dyspnea/tachypnea (>20 breaths/min), and/or auscultatory findings indicative of pulmonary consolidation. The etiology was suspected of being pneumococcal if the patient presented with at least 1 of the following findings: rapid onset of symptoms (≤48 hours), high fever (rectal temperature ≥39°C, or oral temperature ≥38.5°C) accompanied by rigors or chills, pleuritic chest pain, chest radiograph showing an infiltrate, or the presence of Gram-positive cocci on direct sputum stain.13,14Patients were excluded from the study if they presented with a history of hypersensitivity to quinolones or penicillins, prior history of tendinopathy associated with quinolones, or suspected aspiration pneumonia. Patients were not admitted if they had a serious respiratory infection requiring parenteral therapy or mechanical ventilation, a concurrent disease considered likely to interfere with the clinical course of the pneumonia, or neutropenia (neutrophil count <1000 cells/µL). Also excluded were patients suffering from acquired immunodeficiency syndrome who had a CD4 cell count of <200 cells/µL, and those with significant renal impairment (serum creatinine level >3.0 mg/dL [>265 µmol/L]), hepatic disease (baseline alanine aminotransferase or aspartate aminotransferase and/or total bilirubin level more than 3 times the upper limit of normal), serious heart failure, or a life-threatening disease and life expectation of <2 months. Pregnant and lactating women, women in whom pregnancy could not be excluded, and patients hospitalized for >48 hours before the onset of pneumonia were not eligible for entry into the study.Also excluded were patients who had received a systemic antibiotic to treat the current episode of pneumonia for >24 hours prior to enrollment; patients who had received an experimental drug during the previous 3 months; patients with prolonged QT on an electrocardiogram, or who were being treated with drugs to prolong the QT, such as amiodarone, sotalol, disopyramide, quinine, procainamide, or terfenadine.Study ProtocolPatients were evaluated on enrollment into the study (visit 1), after 3 to 5 days of treatment (visit 2), and 3 to 5 days (days 1315; visit 3) and 20 to 28 days (days 3138; visit 4) after the end of treatment.The decision whether or not to hospitalize patients was left to the discretion of the investigator. Adverse events were recorded at every visit, and were classified by the investigator as to their severity and relationship to the medication being studied.MicrobiologyTwo blood samples were obtained for cultures from each patient before treatment was started. At visit 1, samples of bronchopulmonary secretions were also collected for culture. A sample of sputum or bronchial material was obtained by 1 of the following methods: bronchoalveolar lavage (BAL) or protected specimen brush in a telescoping catheter, transtracheal aspirate, or pleural fluid by aspiration of the effusion.Gram's stains were performed on all sputum samples and all bronchial specimens. The quality of the sputum and of the nasotracheal and endotracheal aspirates was evaluated cytologically using a low power lens (100x) and only samples with >25 leukocytes and <10 epithelial cells per field were considered acceptable for culture. In a mixed colony, a count of ≥106 colony forming units (cfu) per mL was required to distinguish the microorganisms considered to be causing the pneumonia from contaminants. The quantitative cut point for the evaluation of the cultures obtained by expectoration and transtracheal aspirate was 106 cfu/mL. The cut points for BAL and protected brush specimens were 104 cfu/mL and 103 cfu/mL, respectively.Antibiotic susceptibility (minimum inhibitory concentration values [MIC]-90) was determined for Gram-positive and Gram-negative pathogens using the E-test (AB biodisk: Solna, Sweden) for both moxifloxacin and amoxicillin as well as for clarithromycin, cefuroxime, and clavulanic amoxicillin-acid.Blood and urine samples were collected at visit 1 for detection of the pneumococcal antigen by counterimmuno-electrophoresis. Blood samples for serological testing for Legionella pneumophila, Mycoplasma pneumoniae, Chlamydia pneumoniae, Chlamydia psittaci and Coxiella burnetii were collected at visits 1 and 4. All the serological tests were carried out at a centralized reference laboratory (Glarif Cerba, Baillet en France, France).Efficacy AnalysisAll the patients who were enrolled in the study and received at least 1 dose of the study medication were evaluated as patients with intention to treat (ITT population). Patients who were given the study medication for a minimum of 48 hours (in the case of clinical failure) or 5 full days (in the case of clinical success) were included in the evaluable population (EP). Efficacy analyses were performed on both populations.The primary efficacy variable was clinical response 3 to 5 days after completion of treatment (visit 3). The patient was considered to be cured when the acute signs and symptoms related to the infection had disappeared, or had improved so much that the patient no longer required additional or alternative antibiotic therapy. Treatment was considered a failure when there was an insufficient reduction of the signs and symptoms of infection such that the patient required additional or alternative antibiotic therapy or died as a consequence of the primary diagnosis (pneumonia). The outcome was classified as undetermined when clinical assessment was not possible (premature withdrawal after less than 2 days of treatment, patient unavailable for evaluation, etc). The early failures (at visit 2) were also classified as failures at visits 3 and 4, and the failures at visit 3 were also considered failures at visit 4.Clinical success was defined as cure in both the evaluable and the ITT populations. Clinical failure in the EP was defined as a failure or relapse (initial or partial resolution of clinical signs and symptoms during the study, but with subsequent recurrence of the clinical condition making further antibiotic therapy necessary within 21 to 28 days after the period of administration of the study drug). Clinical failure in the ITT population was defined as failure/relapse, undetermined, or missing efficacy data.Patients for whom at least 1 pathogen was identified in an acceptable pretreatment culture and who had a valid post-treatment bacteriological evaluation were included in the population of microbiologically valid patients. Infection was also considered to be documented when a pathogen was detected in blood culture, or the pneumococcal antigen was found in the patient's serum or urine, especially if this was associated with a positive culture. In the case of atypical pathogens, infection was considered present if there was a fourfold rise in antibody titers or a value of >64 in the case of L pneumophila, or a single titer immunoglobulin M of >8 for M pneumoniae using immunofluorescence assay, immunoglobulin G of >128 for L pneumophila and C Pneumoniae, or >64 for M pneumoniae.The bacteriological response was classified as eradication (initial pathogen absent during or after treatment), presumed eradication (sampling rendered impossible owing to clinical improvements which made the production of sputum impossible), persistence (repeat isolation of the pathogen during or after completion of treatment), presumed persistence (clinical failure without control culture) or superinfection (isolation of a new pathogen during or after completion of treatment, associated with a recurrence of the clinical signs and a new radiologic infiltrate).Bacteriological success at the end of treatment (visit 3) and on follow up (visit 4) was defined as eradication or presumed eradication. Bacteriological failure at visit 3 was defined as persistence, presumed persistence or superinfection and at visit 4 as persistence, presumed persistence, eradication with reinfection (eradication of the initial causal pathogen at visit 3, but with isolation of a new pathogen before visit 4 associated with a clinical relapse) or eradication with recurrence (eradication of the initial causal pathogen on visit 3, but isolation of the same pathogen before or at visit 4 associated with clinical relapse).Safety AnalysisAll the randomized patients who received at least 1 dose of the study medication were evaluated in the safety analysis. Safety evaluations were carried out throughout the whole study period (from visit 1 to visit 4).ResultsPatientsA total of 84 patients were included in the study. They came from 5 participating Latin American countries. Of these 70 (83.3%) could be evaluated for efficacy and safety at the end of the treatment (visit 3); 34 of the group treated with moxifloxacin and 36 of the group treated with amoxicillin. A total of 37 patients (52.8%) were hospitalized; 17 in the moxifloxacin group and 20 in the amoxicillin group. The characteristics of the patients are given in Table 1.<img src="260v39n09-13051509tab01.gif"></img>Identification of PathogensCausal organisms were cultured pretreatment in 36 of the 70 patients evaluated (51.4%); 19 in the group treated with moxifloxacin, and 17 in the group treated with amoxicillin. Gram-positive pathogens were cultured in samples from 29 patients (80.5%). S pneumoniae was detected in the samples of 28 patients (77.7%). Gram-negative pathogens were cultured in samples from 7 patients (19.4%), the most commonly isolated pathogen being H influenzae in 3 patients (8.3%). No pathogens were isolated in blood cultures (Table 2).<img src="260v39n09-13051509tab02.gif"></img>The serological determinations were positive for atypical microorganisms in 18 of the 70 patients evaluated (25%), mainly M pneumoniae (n=11).Mixed infections were found in 6 patients (8.5%). This was defined as the presence of a positive serology for atypical microorganisms and pretreatment isolation of a causal agent in a positive culture.With respect to pneumococcal etiology, 28 of the 70 patients evaluated (40%) had proven pneumococcal pneumonia, demonstrated by positive sputum culture in 27 patients and by isolation in BAL in 1 case. The susceptibility to penicillin of these 28 strains of S pneumoniae was tested. With the breakpoints traditionally used to ascertain susceptibility to penicillin, 10 strains (35.7%) were shown to be susceptible to penicillin (MIC<0.1 µg/mL), 2 (7.1%) presented high resistance to penicillin (MIC>1 µg/mL) and 16 (57.1%), intermediate resistance (MIC between 0.1 and 1 µg/mL) (Tables 3 and 4). However, no strain of S pneumoniae presented resistance to penicillin as defined by the new criteria of the National Committee for Clinical Laboratory Standards (NCCLS) (MIC>4 µg/mL).15 The initial bacteriological findings were comparable in the 2 treatment groups. With respect to macrolides, 4 strains (14.3%) had an MIC>2 µg/mL for clarithromycin and 1 of them an MIC>8 µg/mL. No differences were observed between the hospitalized patients and the outpatients in the percentage of strains with decreased susceptibility to antibiotics.<img src="260v39n09-13051509tab03.gif"></img><img src="260v39n09-13051509tab04.gif"></img>EfficacyThe clinical success rate in the EP at visit 3 (end of treatment) was 94.1% for moxifloxacin and 91.7% for amoxicillin, and at visit 4 (the follow-up visit) this figure was 91.2% for moxifloxacin and 85.7% for amoxicillin. In the ITT population the clinical success rate at visit 3 was 91.9% of the patients treated with moxifloxacin and 85.4% of those treated with amoxicillin, and at the follow-up visit, 89.2% for moxifloxacin and 84.2% for amoxicillin (Table 5).<img src="260v39n09-13051509tab05.gif"></img>In the EP, 2 of the 34 patients in the group treated with moxifloxacin (5.9%) and 3 of the 36 patients in the group treated with amoxicillin (8.3%) were considered clinical failures at the end-of-treatment visit (visit 3). In the 2 treated with moxifloxacin no pathogen was isolated; however in the 3 treated with amoxicillin, pathogens were isolated (S epidermis [n=1] and H influenzae [n=1]).The bacteriological success rate in the EP at the end of treatment and on follow up (visit 4) was 86.6% in the group treated with moxifloxacin and 84.6% in t he group treated with amoxicillin. The bacteriological success rate at the end of treatment (visit 3) was 88.2% for moxifloxacin and 87.5% for amoxicillin (Table 6).<img src="260v39n09-13051509tab06.gif"></img>Bacteriological failure (persistence, presumed persistence, or persistence with superinfection) at the end of treatment and after follow up occurred in 11.8% and 13.3% respectively, in the group treated with moxifloxacin and in 12.5% and 15.3% respectively in the group treated with amoxicillin. The sample size in the Latin American arm of the study does not have sufficient statistical power to allow for comparisons of efficacy between the 2 treatment groups. The comparison for the study as a whole has been described recently.12The pretreatment MIC values for S pneumoniae ranged between 0.032 and 0.75 mg/L for moxifloxacin and from 0.016 to 1.5 mg/L for amoxicillin. In the cases of H influenzae they ranged from 0.032 to 0.25 mg/L for moxifloxacin and from 0.125 to 12 mg/L for amoxicillin.SafetyDuring treatment adverse events considered by the investigator to be related (possibly or probably) to the study medication occurred in 27 of the 39 patients (69.2%) in the group treated with moxifloxacin and in 20 of the 45 patients (44.4%) in the group treated with amoxicillin.The most frequently recorded adverse events were gastrointestinal disturbances (nausea, vomiting and diarrhea) in the group treated with moxifloxacin and liver function test abnormalities in the amoxicillin group.Drug-related adverse events in both treatment groups were mainly mild to moderate in intensity and were subsequently resolved.Severe drug-related adverse events were observed in 2 patients in the group treated with amoxicillin (pulmonary embolism and pneumonia relapse) and in 1 patient in the group treated with moxifloxacin (myocardial ischemia with ventricular fibrillation). Twelve patients discontinued the study medication owing to an adverse event, 4 in the group treated with moxifloxacin and 8 in the group treated with amoxicillin. Two patients, 1 from each group, died during the study. Neither of these deaths was considered to be related to the study drug treatment.DiscussionThe results of this study reveal a high prevalence of S pneumoniae with reduced susceptibility to penicillin in patients with CAP in Latin America. Moreover, 8.6% of the patients presented mixed infection. These results are relevant to the orientation of empirical treatment of CAP in Latin America.One of the main reasons why the treatment of CAP continues to be a challenge for doctors is the large number of causal organisms and the changing patterns of their susceptibility to different antibiotics. Antibiotic treatment for CAP should be active against the most commonly isolated pathogens and, above all, against S pneumoniae. A growing problem recently has been the appearance of strains of S pneumoniae whose resistance to penicillin is not mediated by beta-lactamase. This resistance of the pneumococcus to penicillin is a worldwide problem that has been increasing in recent years to different degrees in different geographical areas. The highest levels of resistance in Europe have been identified in countries where they account for 50% of the isolations: France, Hungary, Spain, Portugal, and Iceland.16-25 In the USA, the level of resistant strains went from 3% in 1988 to 32% in 1998.26 In Latin America, penicillin resistance is estimated to be around 25%, although this is mainly intermediate resistance, with an MIC between 0.12 and 1 µg/mL.11Our results confirm these high levels of penicillin resistance. Of the 28 strains of pneumococcus isolated, 10 (35.7%) were shown to be susceptible to penicillin, and 18 (64.3%) resistant; 2 strains (7.1%) evidenced high resistance to penicillin and 16 (57.1%) intermediate resistance. It should be noted that this in vitro resistance does not correspond directly with clinical response,27 so that the NCCLS changed the breakpoints for susceptibility to penicillin to 4 µg/mL in 2002.15 None of the pneumococcus isolated in this study had an MIC of >4 µg/mL.Penicillin resistance also occasionally implies cross-resistance with other antibiotics, such as macrolides, sulfamides, and cephalosporins, so that the activity of the new macrolides, such as clarithromycin or azithromycin, against the pneumococcus is often weaker against the penicillin resistant strains.The increase in the patterns of resistance of most of the organisms that cause CAP makes it necessary to search for new antimicrobial agents that can be administered empirically. The number of available therapeutic options has increased thanks to the recent development of the fluoroquinolones, whose activity against S pneumoniae is not affected by resistance to penicillin or macrolides.28,29 The new fluoroquinolones with action against the pneumococcus maintain their activity against S pneumoniae, even against strains highly resistant to penicillin. Within this group moxifloxacin is the drug that presents the greatest activity in vitro against the pneumoccus.28Most etiology studies show that S pneumoniae continues to be the main cause of CAP. The incidence of other pathogens varies geographically and according to the season.3,30-34 The other causal agents in order of frequency are L pneumophila,31Klebsiella pneumoniae32 and H influenzae.32 Occasionally viral agents and C pneumoniae have been isolated with greater frequency than S pneumoniae, especially in the individuals treated as outpatients.34,35Few studies have been conducted to study the etiology of CAP in Latin America. In a study carried out in Brazil it was observed that "atypical agents," including Chlamydia sp, either alone or in mixed infections can be detected in around 50% of cases when serological techniques are used.9It should be remembered that the diagnostic tests have limitations, such that the etiology is unknown in 30% to 50% of CAP patients, although some studies show that most cases in which no etiological diagnosis is reached are due to S pneumoniae.36,37The number of patients with microbiologically valid specimens for our study was 36/84 (42.8%). The pathogens most frequently detected were S pneumoniae (78%), followed in frequency by H influenzae (8.3%) and by M pneumoniae in third place.The role of the "atypical" pathogens is very controversial, given that their frequency as causal agents of CAP depends on the diagnostic tests and criteria used. The term "atypical" is falling into disuse because the clinical syndrome caused by these microorganisms is not distinctive, but it can still be used to refer to a group of microorganisms (M pneumoniae, C pneumoniae and Legionella spp) rather than to a clinical picture. What is more important is that these are in many cases intracellular organisms, a characteristic that limits the activity of some antimicrobial agents, such as the beta-lactams, and the possibility of their causing mixed infection with classical bacteria with a frequency that ranges between 10% and 40% of cases according to studies undertaken.31,38,39 It is difficult to estimate how important these atypical pathogens are, and whether they require specific treatment. However, various studies have shown that in both hospitalized patients and outpatients the clinical course is less complicated when macrolides are used as part of the therapeutic regimen or when a quinolone is used alone.40-42The serological determinations were positive for atypical microorganisms in 25% of the EP, above all M pneumoniae and L pneumophila. Mixed infections were found in 6 patients (8.5%), (defined as the presence of positive serology for atypical microorganisms and the isolation by positive pretreatment culture of a causal agent.Studies designed to investigate the etiology of CAP and its resistance patterns are essential for the orientation of empirical therapy. The new quinolones, such as moxifloxacin, have been shown to be at least as effective as the reference antibiotics in the treatment of CAP.12,13,43*The names of the other members of the CAP 5 Latin American Study Group are shown in the appendix.This study was financed by Bayer AG.AppendixThe members of the CAP 5 Latin American study group are as follows: Abel Jasovich (Argentina); José R. Jardim (Brazil), Marcelo Wolff (Chile), José Alva, Ariel Estrada, Mayra Loera, Juan Morales, Gerardo Rico, Enrique Obispo, and Juan Urueta (Mexico), and Homero Bagnulo (Uruguay).<hr></hr>Correspondence: Dr. M. Miravitlles. Servicio de Neumología (UVIR, escalera 2, planta 3). Hospital Clínic. Villarroel, 170. 08036 Barcelona. Spain. E-mail: <a href="mailto:marcm@clinic.ub.es" class="elsevierStyleCrossRefs"> marcm@clinic.ub.es</a>Manuscript received September 30, 2002. Accepted for publication April 29, 2003." "pdfFichero" => "260v39n09a13051509pdf001.pdf" "tienePdf" => true "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec191403" "palabras" => array:5 [ 0 => "Pneumonia" 1 => "Treatment" 2 => "Antibiotics" 3 => "Resistance" 4 => "Pneumococcus" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec191404" "palabras" => array:5 [ 0 => "Neumonía" 1 => "Tratamiento" 2 => "Antibióticos" 3 => "Resistencia" 4 => "Neumococo" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:1 [ "resumen" => "Since community-acquired pneumonia (CAP) is a common disease with a high morbidity rate, it is important to obtain information concerning its etiology and susceptibility to antibiotics across different geographic areas. This study presents data obtained in 5 Latin American counties in the course of an international clinical trial that evaluated the efficacy and safety of treatment with either moxifloxacin or amoxicillin administered for 10 days to patients suspected of having CAP caused by a pneumococcal infection. Details are given of the pathogens identified, the patterns of sensitivity to antibiotics observed, and the clinical and microbiological results obtained. A total of 84 patients were studied, of whom 70 (83.3%) were evaluated at the end of the trial to determine the efficacy and safety of the treatment received. Gram-positive bacteria were found in samples from 29 patients (80.5%). The pathogen was Streptococcus pneumoniae in 28 of those cases (77.7%). Gram-negative bacteria were found in 7 patients (19.4%), the most common being Haemophilus influenzae in 3 patients (8.3%). The presence of atypical microorganisms was detected in 18 of the 70 patients (25%), mainly Mycobacterium pneumoniae (n=11), and in 6 cases (8.5%) the infection was mixed. Ten strains of S. pneumoniae (35.7%) were shown to be susceptible to penicillin, 2 (7.1%) were highly resistant, and 16 (57.1%) showed moderate resistance. The clinical success rate at the final visit after treatment was 94.1% for moxifloxacin and 91.7% for amoxicillin. The results of this trial demonstrate a high prevalence of S. pneumoniae with reduced susceptibility to penicillin in patients with CAP in Latin America. It also revealed a high incidence of atypical pathogens and mixed infection in 8.6% of patients. This information should be taken into account when establishing protocols for empirical treatment of CAP in Latin America." ] "es" => array:1 [ "resumen" => "La neumonía adquirida en la comunidad (NAC) es una infección frecuente y con una alta morbilidad, por lo que es importante disponer de datos relativos a su etiología y la susceptibilidad a antibióticos en diversas áreas geográficas. En el presente trabajo se recoge la experiencia en 5 países de América Latina participantes en un ensayo clínico internacional que evaluó la eficacia y seguridad del tratamiento con moxifloxacino o amoxicilina, ambos durante 10 días, en pacientes con sospecha de NAC por neumococo. Se detallan los gérmenes aislados, los patrones de sensibilidad a los antibióticos y los resultados clínicos y microbiológicos obtenidos. Se incluyó a un total de 84 pacientes, de los cuales 70 (83,3%) fueron evaluables para determinar la eficacia y seguridad al final del período de tratamiento. Se aislaron grampositivos en muestras de 29 pacientes (80,5%), Streptococcus pneumoniae en 28 casos (77,7%) y gramnegativos en 7 (19,4%), siendo el aislamiento más común Haemophilus influenzae en tres pacientes (8,3%). Se documentó la presencia de microorganismos atípicos en 18 de 70 pacientes (25%), sobre todo Mycoplasma pneumoniae (n = 11) y en 6 casos (8,5%) la infección fue mixta. Diez cepas de S. pneumoniae (35,7%) demostraron ser susceptibles a la penicilina, dos (7,1%) mostraron alta resistencia y 16 (57,1%), resistencia intermedia. La tasa de éxito clínico en la visita final del tratamiento fue del 94,1% para el moxifloxacino y del 91,7% para la amoxicilina. Los resultados del presente estudio demuestran una elevada prevalencia de S. pneumoniae con susceptibilidad reducida a la penicilina en pacientes con NAC en América Latina. Así mismo se encontró una elevada incidencia de gérmenes atípicos y un 8,6% de los pacientes presentó una infección mixta. Estos datos deben valorarse al establecer las pautas de tratamiento empírico para la NAC en América Latina." ] ] "multimedia" => array:12 [ 0 => array:8 [ "identificador" => "tbl1" "etiqueta" => "TABLE 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "copyright" => "Elsevier España" "tabla" => array:1 [ "tablatextoimagen" => array:1 [ 0 => array:1 [ "tablaImagen" => array:1 [ 0 => array:4 [ "imagenFichero" => "260v39n09-13051509tab01.gif" "imagenAlto" => 509 "imagenAncho" => 386 "imagenTamanyo" => 19328 ] ] ] ] ] "descripcion" => array:1 [ "en" => "Baseline Characteristics of ITT patients*" ] ] 1 => array:8 [ "identificador" => "tbl2" "etiqueta" => "TABLE 2" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "copyright" => "Elsevier España" "tabla" => array:1 [ "tablatextoimagen" => array:1 [ 0 => array:1 [ "tablaImagen" => array:1 [ 0 => array:4 [ "imagenFichero" => "260v39n09-13051509tab02.gif" "imagenAlto" => 346 "imagenAncho" => 393 "imagenTamanyo" => 15587 ] ] ] ] ] "descripcion" => array:1 [ "en" => "Pathogens Isolated in Patients Valid for Microbiological Evaluation. 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Moxifloxacino frente a amoxicilina en el tratamiento de la neumonía adquirida en la comunidad en América Latina. Resultados de un ensayo clínico multicéntrico

JR. Jardima, G. Ricob, C. de la Rozac, E. Obispod, J. Uruetae, M. Wolfff, M. Miravitllesc

a Universidade Federal de São Paulo, São Paulo, Brazil.

b Centro Médico Nacional La Raza, Mexico City, Mexico.

c Institut Clínic de Pneumologia i Cirurgia Toràcica, IDIBAPS, Hospital Clínic, Barcelona, Spain.

d Hospital General Tijuana, Tijuana, Mexico.

e INER, Mexico City, Mexico.

f Fundación Arriarán, Santiago de Chile, Chile.

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    "textoCompleto" => "<p class="elsevierStylePara"><span class="elsevierStyleBold">Introduction</span></p><p class="elsevierStylePara"> Community-acquired pneumonia &#40;CAP&#41; is a common infection with high morbidity&#46; The exact incidence of CAP is not known because it is not a reportable disease&#44; but it is estimated that it could range between 1&#46;6 and 13&#46;4 per 1000 people per year&#46;<span class="elsevierStyleSup">1-4</span> Since the morbidity and mortality of CAP are high and the disease represents a major cost to health services all over the world&#44; the treatment prescribed should be as effective as possible&#46; The treatment strategies recommended in the guidelines published by different international institutions are&#44; however&#44; controversial and difficult to standardize for all patients and across different geographical areas&#46;<span class="elsevierStyleSup">5-8</span> One of the main reasons for modifying the established regimens of empirical therapy is the variation in the susceptibility patterns of the most common pathogens&#44; particularly <span class="elsevierStyleItalic">Streptococcus pneumoniae</span> and <span class="elsevierStyleItalic"> Haemophilus influenzae</span>&#46; Relatively few studies have been carried out in Latin America on the etiology of CAP and the patterns of antibiotic susceptibility of its causal agents&#46; In 2 studies carried out in Brazil and Argentina&#44; a high prevalence of atypical pathogens was observed&#46;<span class="elsevierStyleSup">9&#44;10</span> It is also worth noting that the scant data available on resistance indicates that the resistance of the pneumococcus to penicillin may be as high as 25&#37;&#46;<span class="elsevierStyleSup">11</span></p><p class="elsevierStylePara">It is important to obtain data on the etiology of CAP and the patterns of antibiotic susceptibility across different geographical areas&#44; as well as information concerning the efficacy of new antibiotics in this context&#46; This paper brings together data from hospitals in 5 Latin American countries which participated in an international clinical trial undertaken to evaluate the efficacy and safety of treatment with moxifloxacin in comparison with amoxicillin&#44; both administered for 10 days&#44; in adult patients with suspected pneumococcal CAP&#46; This paper presents details of the pathogens isolated and the patterns of sensitivity to traditional antibiotics&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Method</span></p><p class="elsevierStylePara"><span class="elsevierStyleItalic">Study Design</span></p><p class="elsevierStylePara">This was a prospective&#44; multicenter&#44; multinational&#44; controlled&#44; double-blind&#44; randomized study conducted in 82 centers located in 20 countries to compare the efficacy and safety of moxifloxacin and amoxicillin in the treatment of suspected pneumococcal CAP in adult patients&#46; The methodology of this study was recently published elsewhere&#46;<span class="elsevierStyleSup">12</span> The present paper describes the pathogens isolated&#44; the patterns of antibiotic sensitivity&#44; and the clinical and microbiological results obtained in the hospitals located in Latin America&#46; The participating countries were Mexico&#44; with 7 hospitals&#44; and Chile&#44; Argentina&#44; Uruguay and Brazil&#44; with 1 each&#46; Patients eligible for inclusion in the study were randomized to receive one of the following treatments during a 10-day period&#58; 400 mg of moxifloxacin &#40;tablets&#41; once a day&#44; or 500 mg of amoxicillin &#40;2 capsules 3 times a day&#41;&#46; Patients were either hospitalized or treated as outpatients depending on the criteria of each investigator&#46;</p><p class="elsevierStylePara">This study was conducted with approval from the ethics committees in each of the participating countries&#46; Informed consent was obtained from each patient prior to entry into the study&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleItalic">Study Population</span></p><p class="elsevierStylePara">Adult patients &#40;&#8805;18 years of age&#41; presenting with CAP of suspected pneumococcal origin were enrolled in the study&#46; Patients were classified as having CAP if they presented with fever &#40;rectal temperature &#62;38&#46;5&#186;C or oral temperature &#62;38&#46;0&#186;C&#41;&#44; radiologic evidence of pneumonia&#44; and at least one of the following signs or symptoms&#58; purulent sputum&#44; dyspnea&#47;tachypnea &#40;&#62;20 breaths&#47;min&#41;&#44; and&#47;or auscultatory findings indicative of pulmonary consolidation&#46; The etiology was suspected of being pneumococcal if the patient presented with at least 1 of the following findings&#58; rapid onset of symptoms &#40;&#8804;48 hours&#41;&#44; high fever &#40;rectal temperature &#8805;39&#176;C&#44; or oral temperature &#8805;38&#46;5&#176;C&#41; accompanied by rigors or chills&#44; pleuritic chest pain&#44; chest radiograph showing an infiltrate&#44; or the presence of Gram-positive cocci on direct sputum stain&#46;<span class="elsevierStyleSup">13&#44;14</span></p><p class="elsevierStylePara">Patients were excluded from the study if they presented with a history of hypersensitivity to quinolones or penicillins&#44; prior history of tendinopathy associated with quinolones&#44; or suspected aspiration pneumonia&#46; Patients were not admitted if they had a serious respiratory infection requiring parenteral therapy or mechanical ventilation&#44; a concurrent disease considered likely to interfere with the clinical course of the pneumonia&#44; or neutropenia &#40;neutrophil count &#60;1000 cells&#47;&#181;L&#41;&#46; Also excluded were patients suffering from acquired immunodeficiency syndrome who had a CD4 cell count of &#60;200 cells&#47;&#181;L&#44; and those with significant renal impairment &#40;serum creatinine level &#62;3&#46;0 mg&#47;dL &#91;&#62;265 &#181;mol&#47;L&#93;&#41;&#44; hepatic disease &#40;baseline alanine aminotransferase or aspartate aminotransferase and&#47;or total bilirubin level more than 3 times the upper limit of normal&#41;&#44; serious heart failure&#44; or a life-threatening disease and life expectation of &#60;2 months&#46; Pregnant and lactating women&#44; women in whom pregnancy could not be excluded&#44; and patients hospitalized for &#62;48 hours before the onset of pneumonia were not eligible for entry into the study&#46;</p><p class="elsevierStylePara">Also excluded were patients who had received a systemic antibiotic to treat the current episode of pneumonia for &#62;24 hours prior to enrollment&#59; patients who had received an experimental drug during the previous 3 months&#59; patients with prolonged QT on an electrocardiogram&#44; or who were being treated with drugs to prolong the QT&#44; such as amiodarone&#44; sotalol&#44; disopyramide&#44; quinine&#44; procainamide&#44; or terfenadine&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleItalic">Study Protocol</span></p><p class="elsevierStylePara">Patients were evaluated on enrollment into the study &#40;visit 1&#41;&#44; after 3 to 5 days of treatment &#40;visit 2&#41;&#44; and 3 to 5 days &#40;days 13&#173;15&#59; visit 3&#41; and 20 to 28 days &#40;days 31&#173;38&#59; visit 4&#41; after the end of treatment&#46;</p><p class="elsevierStylePara">The decision whether or not to hospitalize patients was left to the discretion of the investigator&#46; Adverse events were recorded at every visit&#44; and were classified by the investigator as to their severity and relationship to the medication being studied&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleItalic">Microbiology</span></p><p class="elsevierStylePara">Two blood samples were obtained for cultures from each patient before treatment was started&#46; At visit 1&#44; samples of bronchopulmonary secretions were also collected for culture&#46; A sample of sputum or bronchial material was obtained by 1 of the following methods&#58; bronchoalveolar lavage &#40;BAL&#41; or protected specimen brush in a telescoping catheter&#44; transtracheal aspirate&#44; or pleural fluid by aspiration of the effusion&#46;</p><p class="elsevierStylePara">Gram&#39;s stains were performed on all sputum samples and all bronchial specimens&#46; The quality of the sputum and of the nasotracheal and endotracheal aspirates was evaluated cytologically using a low power lens &#40;100x&#41; and only samples with &#62;25 leukocytes and &#60;10 epithelial cells per field were considered acceptable for culture&#46; In a mixed colony&#44; a count of &#8805;10<span class="elsevierStyleSup">6</span> colony forming units &#40;cfu&#41; per mL was required to distinguish the microorganisms considered to be causing the pneumonia from contaminants&#46; The quantitative cut point for the evaluation of the cultures obtained by expectoration and transtracheal aspirate was 10<span class="elsevierStyleSup">6</span> cfu&#47;mL&#46; The cut points for BAL and protected brush specimens were 10<span class="elsevierStyleSup">4</span> cfu&#47;mL and 10<span class="elsevierStyleSup">3</span> cfu&#47;mL&#44; respectively&#46;</p><p class="elsevierStylePara">Antibiotic susceptibility &#40;minimum inhibitory concentration values &#91;MIC&#93;-90&#41; was determined for Gram-positive and Gram-negative pathogens using the E-test &#40;AB biodisk&#58; Solna&#44; Sweden&#41; for both moxifloxacin and amoxicillin as well as for clarithromycin&#44; cefuroxime&#44; and clavulanic amoxicillin-acid&#46;</p><p class="elsevierStylePara">Blood and urine samples were collected at visit 1 for detection of the pneumococcal antigen by counterimmuno-electrophoresis&#46; Blood samples for serological testing for <span class="elsevierStyleItalic">Legionella pneumophila&#44; Mycoplasma pneumoniae&#44; Chlamydia pneumoniae&#44; Chlamydia psittaci</span> and <span class="elsevierStyleItalic"> Coxiella burnetii</span> were collected at visits 1 and 4&#46; All the serological tests were carried out at a centralized reference laboratory &#40;Glarif Cerba&#44; Baillet en France&#44; France&#41;&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleItalic">Efficacy Analysis</span></p><p class="elsevierStylePara">All the patients who were enrolled in the study and received at least 1 dose of the study medication were evaluated as patients with intention to treat &#40;ITT population&#41;&#46; Patients who were given the study medication for a minimum of 48 hours &#40;in the case of clinical failure&#41; or 5 full days &#40;in the case of clinical success&#41; were included in the evaluable population &#40;EP&#41;&#46; Efficacy analyses were performed on both populations&#46;</p><p class="elsevierStylePara">The primary efficacy variable was clinical response 3 to 5 days after completion of treatment &#40;visit 3&#41;&#46; The patient was considered to be cured when the acute signs and symptoms related to the infection had disappeared&#44; or had improved so much that the patient no longer required additional or alternative antibiotic therapy&#46; Treatment was considered a failure when there was an insufficient reduction of the signs and symptoms of infection such that the patient required additional or alternative antibiotic therapy or died as a consequence of the primary diagnosis &#40;pneumonia&#41;&#46; The outcome was classified as undetermined when clinical assessment was not possible &#40;premature withdrawal after less than 2 days of treatment&#44; patient unavailable for evaluation&#44; etc&#41;&#46; The early failures &#40;at visit 2&#41; were also classified as failures at visits 3 and 4&#44; and the failures at visit 3 were also considered failures at visit 4&#46;</p><p class="elsevierStylePara">Clinical success was defined as cure in both the evaluable and the ITT populations&#46; Clinical failure in the EP was defined as a failure or relapse &#40;initial or partial resolution of clinical signs and symptoms during the study&#44; but with subsequent recurrence of the clinical condition making further antibiotic therapy necessary within 21 to 28 days after the period of administration of the study drug&#41;&#46; Clinical failure in the ITT population was defined as failure&#47;relapse&#44; undetermined&#44; or missing efficacy data&#46;</p><p class="elsevierStylePara">Patients for whom at least 1 pathogen was identified in an acceptable pretreatment culture and who had a valid post-treatment bacteriological evaluation were included in the population of microbiologically valid patients&#46; Infection was also considered to be documented when a pathogen was detected in blood culture&#44; or the pneumococcal antigen was found in the patient&#39;s serum or urine&#44; especially if this was associated with a positive culture&#46; In the case of atypical pathogens&#44; infection was considered present if there was a fourfold rise in antibody titers or a value of &#62;64 in the case of <span class="elsevierStyleItalic">L pneumophila</span>&#44; or a single titer immunoglobulin M of &#62;8 for <span class="elsevierStyleItalic">M pneumoniae</span> using immunofluorescence assay&#44; immunoglobulin G of &#62;128 for <span class="elsevierStyleItalic">L pneumophila</span> and <span class="elsevierStyleItalic">C Pneumoniae</span>&#44; or &#62;64 for <span class="elsevierStyleItalic">M pneumoniae</span>&#46;</p><p class="elsevierStylePara">The bacteriological response was classified as eradication &#40;initial pathogen absent during or after treatment&#41;&#44; presumed eradication &#40;sampling rendered impossible owing to clinical improvements which made the production of sputum impossible&#41;&#44; persistence &#40;repeat isolation of the pathogen during or after completion of treatment&#41;&#44; presumed persistence &#40;clinical failure without control culture&#41; or superinfection &#40;isolation of a new pathogen during or after completion of treatment&#44; associated with a recurrence of the clinical signs and a new radiologic infiltrate&#41;&#46;</p><p class="elsevierStylePara">Bacteriological success at the end of treatment &#40;visit 3&#41; and on follow up &#40;visit 4&#41; was defined as eradication or presumed eradication&#46; Bacteriological failure at visit 3 was defined as persistence&#44; presumed persistence or superinfection and at visit 4 as persistence&#44; presumed persistence&#44; eradication with reinfection &#40;eradication of the initial causal pathogen at visit 3&#44; but with isolation of a new pathogen before visit 4 associated with a clinical relapse&#41; or eradication with recurrence &#40;eradication of the initial causal pathogen on visit 3&#44; but isolation of the same pathogen before or at visit 4 associated with clinical relapse&#41;&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleItalic">Safety Analysis</span></p><p class="elsevierStylePara">All the randomized patients who received at least 1 dose of the study medication were evaluated in the safety analysis&#46; Safety evaluations were carried out throughout the whole study period &#40;from visit 1 to visit 4&#41;&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Results</span></p><p class="elsevierStylePara"><span class="elsevierStyleItalic">Patients</span></p><p class="elsevierStylePara">A total of 84 patients were included in the study&#46; They came from 5 participating Latin American countries&#46; Of these 70 &#40;83&#46;3&#37;&#41; could be evaluated for efficacy and safety at the end of the treatment &#40;visit 3&#41;&#59; 34 of the group treated with moxifloxacin and 36 of the group treated with amoxicillin&#46; A total of 37 patients &#40;52&#46;8&#37;&#41; were hospitalized&#59; 17 in the moxifloxacin group and 20 in the amoxicillin group&#46; The characteristics of the patients are given in Table 1&#46;</p><p class="elsevierStylePara"><img src="260v39n09-13051509tab01.gif"></img></p><p class="elsevierStylePara"><span class="elsevierStyleItalic">Identification of Pathogens</span></p><p class="elsevierStylePara">Causal organisms were cultured pretreatment in 36 of the 70 patients evaluated &#40;51&#46;4&#37;&#41;&#59; 19 in the group treated with moxifloxacin&#44; and 17 in the group treated with amoxicillin&#46; Gram-positive pathogens were cultured in samples from 29 patients &#40;80&#46;5&#37;&#41;&#46; <span class="elsevierStyleItalic">S pneumoniae</span> was detected in the samples of 28 patients &#40;77&#46;7&#37;&#41;&#46; Gram-negative pathogens were cultured in samples from 7 patients &#40;19&#46;4&#37;&#41;&#44; the most commonly isolated pathogen being <span class="elsevierStyleItalic">H influenzae</span> in 3 patients &#40;8&#46;3&#37;&#41;&#46; No pathogens were isolated in blood cultures &#40;Table 2&#41;&#46;</p><p class="elsevierStylePara"><img src="260v39n09-13051509tab02.gif"></img></p><p class="elsevierStylePara">The serological determinations were positive for atypical microorganisms in 18 of the 70 patients evaluated &#40;25&#37;&#41;&#44; mainly <span class="elsevierStyleItalic">M pneumoniae</span> &#40;n&#61;11&#41;&#46;</p><p class="elsevierStylePara">Mixed infections were found in 6 patients &#40;8&#46;5&#37;&#41;&#46; This was defined as the presence of a positive serology for atypical microorganisms and pretreatment isolation of a causal agent in a positive culture&#46;</p><p class="elsevierStylePara">With respect to pneumococcal etiology&#44; 28 of the 70 patients evaluated &#40;40&#37;&#41; had proven pneumococcal pneumonia&#44; demonstrated by positive sputum culture in 27 patients and by isolation in BAL in 1 case&#46; The susceptibility to penicillin of these 28 strains of <span class="elsevierStyleItalic">S pneumoniae</span> was tested&#46; With the breakpoints traditionally used to ascertain susceptibility to penicillin&#44; 10 strains &#40;35&#46;7&#37;&#41; were shown to be susceptible to penicillin &#40;MIC&#60;0&#46;1 &#181;g&#47;mL&#41;&#44; 2 &#40;7&#46;1&#37;&#41; presented high resistance to penicillin &#40;MIC&#62;1 &#181;g&#47;mL&#41; and 16 &#40;57&#46;1&#37;&#41;&#44; intermediate resistance &#40;MIC between 0&#46;1 and 1 &#181;g&#47;mL&#41; &#40;Tables 3 and 4&#41;&#46; However&#44; no strain of <span class="elsevierStyleItalic">S pneumoniae</span> presented resistance to penicillin as defined by the new criteria of the National Committee for Clinical Laboratory Standards &#40;NCCLS&#41; &#40;MIC&#62;4 &#181;g&#47;mL&#41;&#46;<span class="elsevierStyleSup">15</span> The initial bacteriological findings were comparable in the 2 treatment groups&#46; With respect to macrolides&#44; 4 strains &#40;14&#46;3&#37;&#41; had an MIC&#62;2 &#181;g&#47;mL for clarithromycin and 1 of them an MIC&#62;8 &#181;g&#47;mL&#46; No differences were observed between the hospitalized patients and the outpatients in the percentage of strains with decreased susceptibility to antibiotics&#46;</p><p class="elsevierStylePara"><img src="260v39n09-13051509tab03.gif"></img></p><p class="elsevierStylePara"><img src="260v39n09-13051509tab04.gif"></img></p><p class="elsevierStylePara"><span class="elsevierStyleItalic">Efficacy</span></p><p class="elsevierStylePara">The clinical success rate in the EP at visit 3 &#40;end of treatment&#41; was 94&#46;1&#37; for moxifloxacin and 91&#46;7&#37; for amoxicillin&#44; and at visit 4 &#40;the follow-up visit&#41; this figure was 91&#46;2&#37; for moxifloxacin and 85&#46;7&#37; for amoxicillin&#46; In the ITT population the clinical success rate at visit 3 was 91&#46;9&#37; of the patients treated with moxifloxacin and 85&#46;4&#37; of those treated with amoxicillin&#44; and at the follow-up visit&#44; 89&#46;2&#37; for moxifloxacin and 84&#46;2&#37; for amoxicillin &#40;Table 5&#41;&#46;</p><p class="elsevierStylePara"><img src="260v39n09-13051509tab05.gif"></img></p><p class="elsevierStylePara">In the EP&#44; 2 of the 34 patients in the group treated with moxifloxacin &#40;5&#46;9&#37;&#41; and 3 of the 36 patients in the group treated with amoxicillin &#40;8&#46;3&#37;&#41; were considered clinical failures at the end-of-treatment visit &#40;visit 3&#41;&#46; In the 2 treated with moxifloxacin no pathogen was isolated&#59; however in the 3 treated with amoxicillin&#44; pathogens were isolated &#40;<span class="elsevierStyleItalic">S epidermis</span> &#91;n&#61;1&#93; and <span class="elsevierStyleItalic">H influenzae</span> &#91;n&#61;1&#93;&#41;&#46;</p><p class="elsevierStylePara">The bacteriological success rate in the EP at the end of treatment and on follow up &#40;visit 4&#41; was 86&#46;6&#37; in the group treated with moxifloxacin and 84&#46;6&#37; in t he group treated with amoxicillin&#46; The bacteriological success rate at the end of treatment &#40;visit 3&#41; was 88&#46;2&#37; for moxifloxacin and 87&#46;5&#37; for amoxicillin &#40;Table 6&#41;&#46;</p><p class="elsevierStylePara"><img src="260v39n09-13051509tab06.gif"></img></p><p class="elsevierStylePara">Bacteriological failure &#40;persistence&#44; presumed persistence&#44; or persistence with superinfection&#41; at the end of treatment and after follow up occurred in 11&#46;8&#37; and 13&#46;3&#37; respectively&#44; in the group treated with moxifloxacin and in 12&#46;5&#37; and 15&#46;3&#37; respectively in the group treated with amoxicillin&#46; The sample size in the Latin American arm of the study does not have sufficient statistical power to allow for comparisons of efficacy between the 2 treatment groups&#46; The comparison for the study as a whole has been described recently&#46;<span class="elsevierStyleSup">12</span></p><p class="elsevierStylePara">The pretreatment MIC values for <span class="elsevierStyleItalic">S pneumoniae</span> ranged between 0&#46;032 and 0&#46;75 mg&#47;L for moxifloxacin and from 0&#46;016 to 1&#46;5 mg&#47;L for amoxicillin&#46; In the cases of <span class="elsevierStyleItalic">H influenzae</span> they ranged from 0&#46;032 to 0&#46;25 mg&#47;L for moxifloxacin and from 0&#46;125 to 12 mg&#47;L for amoxicillin&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleItalic">Safety</span></p><p class="elsevierStylePara">During treatment adverse events considered by the investigator to be related &#40;possibly or probably&#41; to the study medication occurred in 27 of the 39 patients &#40;69&#46;2&#37;&#41; in the group treated with moxifloxacin and in 20 of the 45 patients &#40;44&#46;4&#37;&#41; in the group treated with amoxicillin&#46;</p><p class="elsevierStylePara">The most frequently recorded adverse events were gastrointestinal disturbances &#40;nausea&#44; vomiting and diarrhea&#41; in the group treated with moxifloxacin and liver function test abnormalities in the amoxicillin group&#46;</p><p class="elsevierStylePara">Drug-related adverse events in both treatment groups were mainly mild to moderate in intensity and were subsequently resolved&#46;</p><p class="elsevierStylePara">Severe drug-related adverse events were observed in 2 patients in the group treated with amoxicillin &#40;pulmonary embolism and pneumonia relapse&#41; and in 1 patient in the group treated with moxifloxacin &#40;myocardial ischemia with ventricular fibrillation&#41;&#46; Twelve patients discontinued the study medication owing to an adverse event&#44; 4 in the group treated with moxifloxacin and 8 in the group treated with amoxicillin&#46; Two patients&#44; 1 from each group&#44; died during the study&#46; Neither of these deaths was considered to be related to the study drug treatment&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Discussion</span></p><p class="elsevierStylePara">The results of this study reveal a high prevalence of <span class="elsevierStyleItalic">S pneumoniae</span> with reduced susceptibility to penicillin in patients with CAP in Latin America&#46; Moreover&#44; 8&#46;6&#37; of the patients presented mixed infection&#46; These results are relevant to the orientation of empirical treatment of CAP in Latin America&#46;</p><p class="elsevierStylePara">One of the main reasons why the treatment of CAP continues to be a challenge for doctors is the large number of causal organisms and the changing patterns of their susceptibility to different antibiotics&#46; Antibiotic treatment for CAP should be active against the most commonly isolated pathogens and&#44; above all&#44; against <span class="elsevierStyleItalic">S pneumoniae</span>&#46; A growing problem recently has been the appearance of strains of <span class="elsevierStyleItalic">S pneumoniae</span> whose resistance to penicillin is not mediated by beta-lactamase&#46; This resistance of the pneumococcus to penicillin is a worldwide problem that has been increasing in recent years to different degrees in different geographical areas&#46; The highest levels of resistance in Europe have been identified in countries where they account for 50&#37; of the isolations&#58; France&#44; Hungary&#44; Spain&#44; Portugal&#44; and Iceland&#46;<span class="elsevierStyleSup">16-&#173;25</span> In the USA&#44; the level of resistant strains went from 3&#37; in 1988 to 32&#37; in 1998&#46;<span class="elsevierStyleSup">26</span> In Latin America&#44; penicillin resistance is estimated to be around 25&#37;&#44; although this is mainly intermediate resistance&#44; with an MIC between 0&#46;12 and 1 &#181;g&#47;mL&#46;<span class="elsevierStyleSup">11</span></p><p class="elsevierStylePara">Our results confirm these high levels of penicillin resistance&#46; Of the 28 strains of pneumococcus isolated&#44; 10 &#40;35&#46;7&#37;&#41; were shown to be susceptible to penicillin&#44; and 18 &#40;64&#46;3&#37;&#41; resistant&#59; 2 strains &#40;7&#46;1&#37;&#41; evidenced high resistance to penicillin and 16 &#40;57&#46;1&#37;&#41; intermediate resistance&#46; It should be noted that this <span class="elsevierStyleItalic">in vitro</span> resistance does not correspond directly with clinical response&#44;<span class="elsevierStyleSup">27</span> so that the NCCLS changed the breakpoints for susceptibility to penicillin to 4 &#181;g&#47;mL in 2002&#46;<span class="elsevierStyleSup">15</span> None of the pneumococcus isolated in this study had an MIC of &#62;4 &#181;g&#47;mL&#46;</p><p class="elsevierStylePara">Penicillin resistance also occasionally implies cross-resistance with other antibiotics&#44; such as macrolides&#44; sulfamides&#44; and cephalosporins&#44; so that the activity of the new macrolides&#44; such as clarithromycin or azithromycin&#44; against the pneumococcus is often weaker against the penicillin resistant strains&#46;</p><p class="elsevierStylePara">The increase in the patterns of resistance of most of the organisms that cause CAP makes it necessary to search for new antimicrobial agents that can be administered empirically&#46; The number of available therapeutic options has increased thanks to the recent development of the fluoroquinolones&#44; whose activity against <span class="elsevierStyleItalic">S pneumoniae</span> is not affected by resistance to penicillin or macrolides&#46;<span class="elsevierStyleSup">28&#44;29</span> The new fluoroquinolones with action against the pneumococcus maintain their activity against <span class="elsevierStyleItalic">S pneumoniae</span>&#44; even against strains highly resistant to penicillin&#46; Within this group moxifloxacin is the drug that presents the greatest activity <span class="elsevierStyleItalic">in vitro</span> against the pneumoccus&#46;<span class="elsevierStyleSup">28</span></p><p class="elsevierStylePara">Most etiology studies show that <span class="elsevierStyleItalic">S pneumoniae</span> continues to be the main cause of CAP&#46; The incidence of other pathogens varies geographically and according to the season&#46;<span class="elsevierStyleSup">3&#44;30-&#173;34</span> The other causal agents in order of frequency are <span class="elsevierStyleItalic">L pneumophila</span>&#44;<span class="elsevierStyleSup">31</span><span class="elsevierStyleItalic">Klebsiella pneumoniae</span><span class="elsevierStyleSup">32</span> and <span class="elsevierStyleItalic">H influenzae</span>&#46;<span class="elsevierStyleSup">32</span> Occasionally viral agents and <span class="elsevierStyleItalic">C pneumoniae</span> have been isolated with greater frequency than <span class="elsevierStyleItalic">S pneumoniae</span>&#44; especially in the individuals treated as outpatients&#46;<span class="elsevierStyleSup">34&#44;35</span></p><p class="elsevierStylePara">Few studies have been conducted to study the etiology of CAP in Latin America&#46; In a study carried out in Brazil it was observed that &#34;atypical agents&#44;&#34; including <span class="elsevierStyleItalic">Chlamydia</span> sp&#44; either alone or in mixed infections can be detected in around 50&#37; of cases when serological techniques are used&#46;<span class="elsevierStyleSup">9</span></p><p class="elsevierStylePara">It should be remembered that the diagnostic tests have limitations&#44; such that the etiology is unknown in 30&#37; to 50&#37; of CAP patients&#44; although some studies show that most cases in which no etiological diagnosis is reached are due to <span class="elsevierStyleItalic">S pneumoniae</span>&#46;<span class="elsevierStyleSup">36&#44;37</span></p><p class="elsevierStylePara">The number of patients with microbiologically valid specimens for our study was 36&#47;84 &#40;42&#46;8&#37;&#41;&#46; The pathogens most frequently detected were <span class="elsevierStyleItalic">S pneumoniae</span> &#40;78&#37;&#41;&#44; followed in frequency by <span class="elsevierStyleItalic">H influenzae</span> &#40;8&#46;3&#37;&#41; and by <span class="elsevierStyleItalic">M pneumoniae</span> in third place&#46;</p><p class="elsevierStylePara">The role of the &#34;atypical&#34; pathogens is very controversial&#44; given that their frequency as causal agents of CAP depends on the diagnostic tests and criteria used&#46; The term &#34;atypical&#34; is falling into disuse because the clinical syndrome caused by these microorganisms is not distinctive&#44; but it can still be used to refer to a group of microorganisms &#40;<span class="elsevierStyleItalic">M pneumoniae</span>&#44; <span class="elsevierStyleItalic">C pneumoniae</span> and <span class="elsevierStyleItalic"> Legionella</span> spp&#41; rather than to a clinical picture&#46; What is more important is that these are in many cases intracellular organisms&#44; a characteristic that limits the activity of some antimicrobial agents&#44; such as the beta-lactams&#44; and the possibility of their causing mixed infection with classical bacteria with a frequency that ranges between 10&#37; and 40&#37; of cases according to studies undertaken&#46;<span class="elsevierStyleSup">31&#44;38&#44;39</span> It is difficult to estimate how important these atypical pathogens are&#44; and whether they require specific treatment&#46; However&#44; various studies have shown that in both hospitalized patients and outpatients the clinical course is less complicated when macrolides are used as part of the therapeutic regimen or when a quinolone is used alone&#46;<span class="elsevierStyleSup">40&#173;-42</span></p><p class="elsevierStylePara">The serological determinations were positive for atypical microorganisms in 25&#37; of the EP&#44; above all <span class="elsevierStyleItalic">M pneumoniae</span> and <span class="elsevierStyleItalic">L pneumophila</span>&#46; Mixed infections were found in 6 patients &#40;8&#46;5&#37;&#41;&#44; &#40;defined as the presence of positive serology for atypical microorganisms and the isolation by positive pretreatment culture of a causal agent&#46;</p><p class="elsevierStylePara">Studies designed to investigate the etiology of CAP and its resistance patterns are essential for the orientation of empirical therapy&#46; The new quinolones&#44; such as moxifloxacin&#44; have been shown to be at least as effective as the reference antibiotics in the treatment of CAP&#46;<span class="elsevierStyleSup">12&#44;13&#44;43</span></p><p class="elsevierStylePara">&#42;The names of the other members of the CAP 5 Latin American Study Group are shown in the appendix&#46;</p><p class="elsevierStylePara">This study was financed by Bayer AG&#46;</p><p class="elsevierStylePara">Appendix</p><p class="elsevierStylePara">The members of the CAP 5 Latin American study group are as follows&#58; Abel Jasovich &#40;Argentina&#41;&#59; Jos&#233; R&#46; Jardim &#40;Brazil&#41;&#44; Marcelo Wolff &#40;Chile&#41;&#44; Jos&#233; Alva&#44; Ariel Estrada&#44; Mayra Loera&#44; Juan Morales&#44; Gerardo Rico&#44; Enrique Obispo&#44; and Juan Urueta &#40;Mexico&#41;&#44; and Homero Bagnulo &#40;Uruguay&#41;&#46;</p><hr></hr><p class="elsevierStylePara">Correspondence&#58; Dr&#46; M&#46; Miravitlles&#46;<br></br> Servicio de Neumolog&#237;a &#40;UVIR&#44; escalera 2&#44; planta 3&#41;&#46; Hospital Cl&#237;nic&#46;<br></br> Villarroel&#44; 170&#46; 08036 Barcelona&#46; Spain&#46;<br></br> E-mail&#58; <a href="mailto&#58;marcm&#64;clinic&#46;ub&#46;es" class="elsevierStyleCrossRefs"> marcm&#64;clinic&#46;ub&#46;es</a></p><p class="elsevierStylePara">Manuscript received September 30&#44; 2002&#46; Accepted for publication April 29&#44; 2003&#46;</p>"
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        "resumen" => "Since community-acquired pneumonia &#40;CAP&#41; is a common disease with a high morbidity rate&#44; it is important to obtain information concerning its etiology and susceptibility to antibiotics across different geographic areas&#46; This study presents data obtained in 5 Latin American counties in the course of an international clinical trial that evaluated the efficacy and safety of treatment with either moxifloxacin or amoxicillin administered for 10 days to patients suspected of having CAP caused by a pneumococcal infection&#46; Details are given of the pathogens identified&#44; the patterns of sensitivity to antibiotics observed&#44; and the clinical and microbiological results obtained&#46; A total of 84 patients were studied&#44; of whom 70 &#40;83&#46;3&#37;&#41; were evaluated at the end of the trial to determine the efficacy and safety of the treatment received&#46; Gram-positive bacteria were found in samples from 29 patients &#40;80&#46;5&#37;&#41;&#46; The pathogen was Streptococcus pneumoniae in 28 of those cases &#40;77&#46;7&#37;&#41;&#46; Gram-negative bacteria were found in 7 patients &#40;19&#46;4&#37;&#41;&#44; the most common being Haemophilus influenzae in 3 patients &#40;8&#46;3&#37;&#41;&#46; The presence of atypical microorganisms was detected in 18 of the 70 patients &#40;25&#37;&#41;&#44; mainly Mycobacterium pneumoniae &#40;n&#61;11&#41;&#44; and in 6 cases &#40;8&#46;5&#37;&#41; the infection was mixed&#46; Ten strains of S&#46; pneumoniae &#40;35&#46;7&#37;&#41; were shown to be susceptible to penicillin&#44; 2 &#40;7&#46;1&#37;&#41; were highly resistant&#44; and 16 &#40;57&#46;1&#37;&#41; showed moderate resistance&#46; The clinical success rate at the final visit after treatment was 94&#46;1&#37; for moxifloxacin and 91&#46;7&#37; for amoxicillin&#46; The results of this trial demonstrate a high prevalence of S&#46; pneumoniae with reduced susceptibility to penicillin in patients with CAP in Latin America&#46; It also revealed a high incidence of atypical pathogens and mixed infection in 8&#46;6&#37; of patients&#46; This information should be taken into account when establishing protocols for empirical treatment of CAP in Latin America&#46;"
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        "resumen" => "La neumon&#237;a adquirida en la comunidad &#40;NAC&#41; es una infecci&#243;n frecuente y con una alta morbilidad&#44; por lo que es importante disponer de datos relativos a su etiolog&#237;a y la susceptibilidad a antibi&#243;ticos en diversas &#225;reas geogr&#225;ficas&#46; En el presente trabajo se recoge la experiencia en 5 pa&#237;ses de Am&#233;rica Latina participantes en un ensayo cl&#237;nico internacional que evalu&#243; la eficacia y seguridad del tratamiento con moxifloxacino o amoxicilina&#44; ambos durante 10 d&#237;as&#44; en pacientes con sospecha de NAC por neumococo&#46; Se detallan los g&#233;rmenes aislados&#44; los patrones de sensibilidad a los antibi&#243;ticos y los resultados cl&#237;nicos y microbiol&#243;gicos obtenidos&#46; Se incluy&#243; a un total de 84 pacientes&#44; de los cuales 70 &#40;83&#44;3&#37;&#41; fueron evaluables para determinar la eficacia y seguridad al final del per&#237;odo de tratamiento&#46; Se aislaron grampositivos en muestras de 29 pacientes &#40;80&#44;5&#37;&#41;&#44; Streptococcus pneumoniae en 28 casos &#40;77&#44;7&#37;&#41; y gramnegativos en 7 &#40;19&#44;4&#37;&#41;&#44; siendo el aislamiento m&#225;s com&#250;n Haemophilus influenzae en tres pacientes &#40;8&#44;3&#37;&#41;&#46; Se document&#243; la presencia de microorganismos at&#237;picos en 18 de 70 pacientes &#40;25&#37;&#41;&#44; sobre todo Mycoplasma pneumoniae &#40;n &#61; 11&#41; y en 6 casos &#40;8&#44;5&#37;&#41; la infecci&#243;n fue mixta&#46; Diez cepas de S&#46; pneumoniae &#40;35&#44;7&#37;&#41; demostraron ser susceptibles a la penicilina&#44; dos &#40;7&#44;1&#37;&#41; mostraron alta resistencia y 16 &#40;57&#44;1&#37;&#41;&#44; resistencia intermedia&#46; La tasa de &#233;xito cl&#237;nico en la visita final del tratamiento fue del 94&#44;1&#37; para el moxifloxacino y del 91&#44;7&#37; para la amoxicilina&#46; Los resultados del presente estudio demuestran una elevada prevalencia de S&#46; pneumoniae con susceptibilidad reducida a la penicilina en pacientes con NAC en Am&#233;rica Latina&#46; As&#237; mismo se encontr&#243; una elevada incidencia de g&#233;rmenes at&#237;picos y un 8&#44;6&#37; de los pacientes present&#243; una infecci&#243;n mixta&#46; Estos datos deben valorarse al establecer las pautas de tratamiento emp&#237;rico para la NAC en Am&#233;rica Latina&#46;"
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Article information

ISSN: 15792129
Original language: English

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Year/Month	Html	Pdf	Total

2024 November	20	2	22
2024 October	160	23	183
2024 September	151	16	167
2024 August	138	36	174
2024 July	109	30	139
2024 June	180	29	209
2024 May	131	36	167
2024 April	94	23	117
2024 March	71	38	109
2024 February	48	43	91
2023 March	15	4	19
2023 February	103	29	132
2023 January	146	39	185
2022 December	120	52	172
2022 November	141	40	181
2022 October	103	58	161
2022 September	78	41	119
2022 August	98	47	145
2022 July	102	62	164
2022 June	108	39	147
2022 May	102	39	141
2022 April	113	52	165
2022 March	141	67	208
2022 February	192	70	262
2022 January	191	82	273
2021 December	100	45	145
2021 November	117	60	177
2021 October	129	49	178
2021 September	124	43	167
2021 August	131	42	173
2021 July	164	44	208
2021 June	184	47	231
2021 May	273	40	313
2021 April	576	117	693
2021 March	229	15	244
2021 February	169	33	202
2021 January	195	18	213
2020 December	192	27	219
2020 November	207	10	217
2020 October	186	27	213
2020 September	156	15	171
2020 August	166	12	178
2020 July	156	25	181
2020 June	149	7	156
2020 May	183	29	212
2020 April	232	26	258
2020 March	222	29	251
2020 February	178	15	193
2020 January	146	21	167
2019 December	154	23	177
2019 November	115	17	132
2019 October	135	18	153
2019 September	100	22	122
2019 August	74	17	91
2019 July	71	15	86
2019 June	86	15	101
2019 May	98	35	133
2019 April	128	33	161
2019 March	158	23	181
2019 February	133	13	146
2019 January	108	16	124
2018 December	82	19	101
2018 November	82	16	98
2018 October	96	24	120
2018 September	85	11	96
2018 May	24	0	24
2018 April	58	5	63
2018 March	66	3	69
2018 February	51	9	60
2018 January	55	7	62
2017 December	56	2	58
2017 November	49	6	55
2017 October	27	10	37
2017 September	48	7	55
2017 August	65	6	71
2017 July	75	3	78
2017 June	119	23	142
2017 May	98	9	107
2017 April	92	10	102
2017 March	99	5	104
2017 February	60	5	65
2017 January	60	2	62
2016 December	74	5	79
2016 November	91	8	99
2016 October	115	15	130
2016 September	137	13	150
2016 August	101	13	114
2016 July	46	5	51
2016 May	1	0	1
2016 March	2	0	2
2016 February	1	0	1
2015 December	3	0	3
2015 October	65	3	68
2015 September	68	18	86
2015 August	66	20	86
2015 July	44	10	54
2015 June	50	7	57
2015 May	61	10	71
2015 April	43	13	56
2015 March	40	7	47
2015 February	48	5	53
2015 January	52	5	57
2014 December	55	7	62
2014 November	53	8	61
2014 October	66	10	76
2014 September	45	9	54
2014 August	53	9	62
2014 July	62	10	72
2014 June	56	9	65
2014 May	66	11	77
2014 April	56	8	64
2014 March	63	15	78
2014 February	53	14	67
2014 January	39	9	48
2013 December	49	10	59
2013 November	39	5	44
2013 October	56	14	70
2013 September	55	7	62
2013 August	38	12	50
2013 July	54	16	70
2013 June	27	10	37
2013 May	31	7	38
2013 April	18	10	28
2013 March	9	7	16

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