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.