title: An open label, multicenter, non-comparative study of the efficacy and safety of oral gatifloxacin in the treatment of community-acquired pneumonia: a Brazilian study in five centers.
abstract: We made an open label, multicenter, non-comparative study to assess the efficacy and safety of oral gatifloxacin, 400 mg PO given once-daily during 7 to 14 days for the treatment of adult outpatients with community-acquired pneumonia at five Brazilian medical facilities. Among the 86 subjects available for clinical evaluation, 84 (98%) were cured. The bacteriological eradication and presumed eradication rate was 98% (52/53) among the 44 (51%) patients who were bacteriologically evaluated. Drug-related adverse events were reported by 27% of the patients, diarrhea being the most frequent, occurring in 12% of patients. Adverse events were considered mild (89%) or moderate (11%). We conclude that a 7-14 day course of gatifloxacin, 400 mg PO given once daily is safe and effective for the treatment of community-acquired pneumonia. The drug had a favorable safety profile and a good clinical and bacteriological efficacy.
authors.affiliation: Infectious Diseases Department, University of São Paulo Medical School, São Paulo, SP, Brazil. ac_nicodemo@uol.com.br
authors.forename: Antônio Carlos
authors.initials: AC
authors.lastname: Nicodemo
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001938:Brazil; D017714:Community-Acquired Infections / Q000188:drug therapy / Q000382:microbiology; D005260:Female; D024841:Fluoroquinolones; D000077734:Gatifloxacin; D006193:Haemophilus influenzae / Q000187:drug effects; D006801:Humans; D008297:Male; D018410:Pneumonia, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D013296:Streptococcus pneumoniae / Q000187:drug effects; D016896:Treatment Outcome
chemical_list: D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D000077734:Gatifloxacin