Efficacy and safety of gemifloxacin 320 mg once-daily for 7 days in the treatment of adult lower respiratory tract infections.

Abstract

An open-label, non-comparative study assessed the clinical and bacteriological efficacy of gemifloxacin (320 mg, once-daily for 7 days) in lower respiratory tract infections (LRTI). Patients with acute exacerbation of chronic bronchitis (AECB, n=261) or community-acquired pneumonia (CAP, n=216) were enrolled into the study. Clinical success rates at follow-up (days 21-28) in the intent-to-treat (ITT) population were high, 83.1% in AECB patients (95% CI: 77.9, 87.4) and 82.9% in CAP patients (95% CI: 77.0, 87.5). High bacteriological success rates were achieved (bacteriological ITT population), 91.2% (52/57) in AECB patients (95% CI: 80.0, 96.7) and 77.9% (60/77) in CAP patients (95% CI: 66.8, 86.3). Gemifloxacin was well tolerated with a low incidence of adverse events. Gemifloxacin treatment resulted in high clinical and bacteriological success rates and is a well-tolerated therapy for the treatment of LRTIs.

• Authors: P Ball, T M File, M Twynholm, T Henkel
• Journal: International journal of antimicrobial agents (Int J Antimicrob Agents) Vol. 18 Issue 1 Pg. 19-27 (Jul 2001) ISSN: 0924-8579 [Print] Netherlands
• PMID: 11463522 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Infective Agents
• Fluoroquinolones
• Naphthyridines
• Gemifloxacin

Topics

• Adult
• Aged
• Anti-Infective Agents (administration & dosage, adverse effects, pharmacology, therapeutic use)
• Bronchitis (drug therapy, microbiology)
• Chronic Disease
• Community-Acquired Infections (drug therapy, microbiology)
• Drug Administration Schedule
• Female
• Fluoroquinolones
• Gemifloxacin
• Gram-Negative Bacterial Infections (drug therapy, microbiology)
• Haemophilus Infections (drug therapy, microbiology)
• Humans
• Klebsiella Infections (drug therapy, microbiology)
• Male
• Middle Aged
• Naphthyridines (administration & dosage, adverse effects, pharmacology, therapeutic use)
• Pneumococcal Infections (drug therapy, microbiology)
• Pneumonia, Bacterial (drug therapy, microbiology)
• Staphylococcal Infections (drug therapy, microbiology)
• Treatment Failure