title: Gemifloxacin once daily for 5 days versus 7 days for the treatment of community-acquired pneumonia: a randomized, multicentre, double-blind study.
abstract: OBJECTIVE
  Short-course therapy has been advocated for the treatment of community-acquired pneumonia (CAP). We compared the efficacy and safety of 5 and 7 day courses of gemifloxacin for outpatient treatment of mild-moderate CAP.
  
  
  METHODS
  In a multicentre, double-blind, parallel group study, patients were randomized to receive 320 mg of oral gemifloxacin once daily for 5 or 7 days. Over 95% of all patients in each cohort had a Fine score of <or=III. The primary efficacy endpoint was clinical cure at follow-up (days 24-30). Secondary outcomes were clinical and bacteriological responses at the end of therapy (days 7-9) and bacteriological and radiological responses at follow-up. Adverse events (AEs) were also monitored.
  
  
  RESULTS
  In a total of 469 per protocol (PP) patients, clinical resolution at follow-up was 95% and 92% for 5 and 7 day treatments, respectively [95% confidence interval (CI) -1.48, 7.42], indicating non-inferiority of 5 day treatment. Clinical resolution at the end of therapy was 96% for both regimens (95% CI -3.85, 3.42). Bacteriological response rates in PP patients at the end of therapy were 94% and 96% for 5 and 7 day groups, respectively (95% CI -8.27, 3.25) and 91% for both groups at follow-up (95% CI -6.89, 7.93). Radiological success in PP patients at follow-up was 98% and 93% in 5 and 7 day groups, respectively (95% CI 0.35, 7.91). Pre-therapy pathogens were identified in 242 (47.3%) patients, most commonly Streptococcus pneumoniae. Frequency of treatment-related AEs was 21% in both cohorts with discontinuation rates of 1.2% and 2% in the 5 and 7 day groups, respectively. A lower incidence of rash was observed in the 5 day cohort (0.4%) versus the 7 day cohort (2.8%) (P=0.04).
  
  
  CONCLUSIONS
  Gemifloxacin once daily for 5 days is not inferior to 7 days in the PP population with respect to clinical, bacteriological and radiological efficacy. Further work is needed, however, to explore whether fewer treatment days would improve patient compliance and reduce the incidence of AEs.
authors.affiliation: Northeastern Ohio Universities College of Medicine, Rootstown, OH and Summa Health System, 75 Arch Street, Suite 105, Akron, OH 44304, USA. filet@summa-health.org
authors.forename: Thomas M
authors.initials: TM
authors.lastname: File
authors.forename: Lionel A
authors.initials: LA
authors.lastname: Mandell
authors.forename: Glenn
authors.initials: G
authors.lastname: Tillotson
authors.forename: Kosta
authors.initials: K
authors.lastname: Kostov
authors.forename: Ognian
authors.initials: O
authors.lastname: Georgiev
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D017714:Community-Acquired Infections / Q000188:drug therapy* / Q000382:microbiology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000077735:Gemifloxacin; D006801:Humans; D008297:Male; D008875:Middle Aged; D009287:Naphthyridines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D018410:Pneumonia, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D011018:Pneumonia, Pneumococcal / Q000188:drug therapy / Q000382:microbiology; D013296:Streptococcus pneumoniae / Q000302:isolation & purification; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D024841:Fluoroquinolones; D009287:Naphthyridines; D000077735:Gemifloxacin