title: Comparison of 5-day, short-course gatifloxacin therapy with 7-day gatifloxacin therapy and 10-day clarithromycin therapy for acute exacerbation of chronic bronchitis.
abstract: BACKGROUND
  The ideal duration of antibiotic therapy for acute exacerbation of chronic bronchitis (AECB) remains controversial.
  
  
  OBJECTIVE
  This study compared short-course, 5-day gatifloxacin treatment with standard 10-day clarithromycin treatment in patients with AECB; 7-day gatifloxacin therapy was a secondary comparator.
  
  
  METHODS
  This was a multicenter, prospective, randomized, double-blind study in which adult outpatients with AECB were randomized to 1 of 3 treatment groups: 5 days of gatifloxacin, 7 days of gatifloxacin, or 10 days of clarithromycin. Clinical cure and microbiologic eradication rates were determined 7 to 14 days after the completion of antibiotic treatment.
  
  
  RESULTS
  A total of 527 patients with AECB were enrolled and treated with study drug (174, gatifloxacin 5-day; 175, gatifloxacin 7-day; 178, clarithromycin 10-day). Most patients (82%) had type 1 (severe) exacerbations, and a bacterial pathogen was isolated from pretreatmer, sputum samples in 59% of patients. The overall clinical cure rates among clinically evaluable patients were comparable between groups: 89% (135/151 patients) in the gatifloxacin 5-day group; 88% (136/154) in the gatifloxacin 7-day group; and 89% (145/163) in the clarithromycin 10-day group. The 95% CIs for the differences in response rates were -6.1 to 7.0 for gatifloxacin 5-day versus clarithromycin, -8.9 to 5.0 for gatifloxacin 7-day versus clarithromycin, and -5.5 to 8.0 for gatifloxacin 5-day versus 7-day. These observations did not appear to be affected by use of corticosteroids or smoking status, type of exacerbation, or duration of current episode. The microbiologic eradication rate among microbiologically evaluable pathogens was >90% in all treatment groups. No clinically meaningful differences were noted in the incidence of drug-related adverse events.
  
  
  CONCLUSIONS
  Short-course, 5-day gatifloxacin therapy in patients with AECB resulted in clinical cure and microbiologic eradication rates comparable to those of standard 7- and 10-day therapies.
authors.affiliation: Pulmonary Associates, Phoenix, Arizona 85020, USA. mgotfried@pol.net
authors.forename: M H
authors.initials: MH
authors.lastname: Gotfried
authors.forename: C A
authors.initials: CA
authors.lastname: DeAbate
authors.forename: C
authors.initials: C
authors.lastname: Fogarty
authors.forename: C P
authors.initials: CP
authors.lastname: Mathew
authors.forename: W N
authors.initials: WN
authors.lastname: Sokol
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001991:Bronchitis / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D024841:Fluoroquinolones; D000077734:Gatifloxacin; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D000077734:Gatifloxacin