Multicenter, Postmarketing Assessment of Levofloxacin in the Treatment of Adults with Community-Acquired Pneumonia

Abstract

This phase IV, multicenter, open-label trial was designed to provide confirmation of the efficacy and safety of levofloxacin, 500 mg once daily, in a large population of "real-world" patients with community-acquired pneumonia (CAP). For 410 (24%) of the 1730 patients in the intent-to-treat population, a pathogen was identified by culture at admission. Of these pathogens, 262 (64%) were Streptococcus pneumoniae, 85 (21%) were Haemophilus influenzae, and 65 (16%) were Staphylococcus aureus. A total of 1095 patients in the intent-to-treat population were clinically evaluable, and the rate of clinical success for these patients was 94% (a cure was achieved for 83% of the patients, and an improvement in condition was experienced by 11%). The clinical success rate for the 188 clinically evaluable patients with S. pneumoniae infections was 93%. The most-frequent adverse events that were considered to be treatment related were nausea (0.9%), rash (0.5%), diarrhea (0.4%), and vomiting (0.4%). The results of the present study confirm those of previous phase III clinical trials showing that levofloxacin, 500 mg once daily, is an effective and well-tolerated therapy for community-acquired pneumonia.