Active Ingredients: Amoxicillin
Adverse events were recorded at every visit, and were classified by the investigator as to their severity and relationship to the medication being studied. Microbiology Two 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. Antibiotic susceptibility minimum inhibitory concentration values -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.Amoxicillin, cefadroxil, monobasic sodium phosphate, dibasic. Jump To 2.
All the serological tests were carried out at a centralized reference laboratory Glarif Cerba, Baillet en France, France. Efficacy Analysis 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 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. 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.
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 Analysis All 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. Results Patients A total of 84 patients were included in the study.
They came from 5 participating Latin American countries.