Journal Article

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

B. Akpunonu, J. Michaelis, C. N. Uy, A. M. Tennenberg, B. A. Wiesinger, R. Karim, J. Scott Marshall and J. B. Kahn

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 38, issue Supplement_1, pages S5-S15
Published in print January 2004 | ISSN: 1058-4838
Published online January 2004 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/378405
Multicenter, Postmarketing Assessment of Levofloxacin in the Treatment of Adults with Community-Acquired Pneumonia

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This phase IV, multicenter, open-label trial was designedto 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% (acure 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.

Journal Article.  5542 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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