title: 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.affiliation: Saint Andrews, Fife, Scotland KY16 8XU, UK. peter.ball@aol.com
authors.forename: P
authors.initials: P
authors.lastname: Ball
authors.forename: T M
authors.initials: TM
authors.lastname: File
authors.forename: M
authors.initials: M
authors.lastname: Twynholm
authors.forename: T
authors.initials: T
authors.lastname: Henkel
mesh_terms: D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001991:Bronchitis / Q000188:drug therapy* / Q000382:microbiology; D002908:Chronic Disease; D017714:Community-Acquired Infections / Q000188:drug therapy / Q000382:microbiology; D004334:Drug Administration Schedule; D005260:Female; D024841:Fluoroquinolones; D000077735:Gemifloxacin; D016905:Gram-Negative Bacterial Infections / Q000188:drug therapy / Q000382:microbiology; D006192:Haemophilus Infections / Q000188:drug therapy / Q000382:microbiology; D006801:Humans; D007710:Klebsiella Infections / Q000188:drug therapy / Q000382:microbiology; D008297:Male; D008875:Middle Aged; D009287:Naphthyridines / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D011008:Pneumococcal Infections / Q000188:drug therapy / Q000382:microbiology; D018410:Pneumonia, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D013203:Staphylococcal Infections / Q000188:drug therapy / Q000382:microbiology; D017211:Treatment Failure
chemical_list: D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D009287:Naphthyridines; D000077735:Gemifloxacin