title: Telithromycin is as effective as amoxicillin/clavulanate in acute exacerbations of chronic bronchitis.
abstract: This randomized, double-blind study evaluated the efficacy and safety of a short, 5-day course of telithromycin, a new ketolide antibacterial, compared with a standard 10-day course of amoxicillin/clavulanate, in the treatment of acute exacerbations of chronic bronchitis (AECB). The study enrolled 325 adult patients with AECB and a history of chronic obstructive pulmonary disease (COPD). Patients received either telithromycin 800 mg once daily (qd) for 5 days (followed by placebo for 5 days) or amoxicillin/clavulanate 500/125 mg three times daily (tid) for 10 days. Clinical cure rates for telithromycin post-therapy (Days 17-21, test-of-cure) and late post-therapy (Days 31-36) were 86.1 and 78.1%, respectively; 82.1 and 75.0% for amoxicillin/clavulanate. Excellent clinical cure rates were also observed for high-risk patients. Bacteriologic outcome was satisfactory for 69.2% of telithromycin recipients vs 70.0% for amoxicillin/clavulanate recipients. Both treatments were generally well tolerated, although the frequency of drug-related adverse events was almost two-fold higher for amoxicillin/clavulanate (25.0 vs. 13.1%). Thus, a 5-day course of telithromycin 800 mg qd is an effective and well-tolerated alternative to a standard 10-day course of amoxicillin/clavulanate 500/125 mg tid for first-line empiric treatment of AECB in adults with COPD.
authors.affiliation: Xavier Bichat School of Medicine, Paris, France. michel.aubier@bch.ap-hop-paris.fr
authors.forename: M
authors.initials: M
authors.lastname: Aubier
authors.forename: P M
authors.initials: PM
authors.lastname: Aldons
authors.forename: A
authors.initials: A
authors.lastname: Leak
authors.forename: D D
authors.initials: DD
authors.lastname: McKeith
authors.forename: B
authors.initials: B
authors.lastname: Leroy
authors.forename: M
authors.initials: M
authors.lastname: Rangaraju
authors.forename: C
authors.initials: C
authors.lastname: Bienfait-Beuzon
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000009:adverse effects / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D029481:Bronchitis, Chronic / Q000188:drug therapy* / Q000382:microbiology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D048628:Ketolides; D008173:Lung Diseases, Obstructive / Q000188:drug therapy / Q000382:microbiology; D018942:Macrolides; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D048628:Ketolides; D018942:Macrolides; D019980:Amoxicillin-Potassium Clavulanate Combination; C106791:telithromycin