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.
Publication types
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Clinical Trial
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Clinical Trial, Phase III
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Multicenter Study
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Research Support, Non-U.S. Gov't
MeSH terms
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Adult
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Aged
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Anti-Infective Agents / administration & dosage
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Anti-Infective Agents / adverse effects
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Anti-Infective Agents / pharmacology
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Anti-Infective Agents / therapeutic use*
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Bronchitis / drug therapy*
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Bronchitis / microbiology
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Chronic Disease
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Community-Acquired Infections / drug therapy
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Community-Acquired Infections / microbiology
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Drug Administration Schedule
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Female
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Fluoroquinolones*
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Gemifloxacin
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Gram-Negative Bacterial Infections / drug therapy
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Gram-Negative Bacterial Infections / microbiology
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Haemophilus Infections / drug therapy
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Haemophilus Infections / microbiology
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Humans
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Klebsiella Infections / drug therapy
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Klebsiella Infections / microbiology
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Male
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Middle Aged
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Naphthyridines / administration & dosage
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Naphthyridines / adverse effects
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Naphthyridines / pharmacology
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Naphthyridines / therapeutic use*
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Pneumococcal Infections / drug therapy
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Pneumococcal Infections / microbiology
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Pneumonia, Bacterial / drug therapy*
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Pneumonia, Bacterial / microbiology
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Staphylococcal Infections / drug therapy
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Staphylococcal Infections / microbiology
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Treatment Failure
Substances
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Anti-Infective Agents
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Fluoroquinolones
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Naphthyridines
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Gemifloxacin