Telithromycin is as effective as amoxicillin/clavulanate in acute exacerbations of chronic bronchitis

Respir Med. 2002 Nov;96(11):862-71. doi: 10.1053/rmed.2002.1382.


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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Amoxicillin-Potassium Clavulanate Combination / adverse effects
  • Amoxicillin-Potassium Clavulanate Combination / therapeutic use*
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Bronchitis, Chronic / drug therapy*
  • Bronchitis, Chronic / microbiology
  • Double-Blind Method
  • Drug Therapy, Combination / adverse effects
  • Drug Therapy, Combination / therapeutic use*
  • Female
  • Humans
  • Ketolides*
  • Lung Diseases, Obstructive / drug therapy
  • Lung Diseases, Obstructive / microbiology
  • Macrolides*
  • Male
  • Middle Aged
  • Treatment Outcome


  • Anti-Bacterial Agents
  • Ketolides
  • Macrolides
  • Amoxicillin-Potassium Clavulanate Combination
  • telithromycin