Once-daily, 3-day azithromycin versus a three-times-daily, 10-day course of co-amoxiclav in the treatment of adults with lower respiratory tract infections: results of a randomized, double-blind comparative study

J Antimicrob Chemother. 1996 Jun:37 Suppl C:93-101. doi: 10.1093/jac/37.suppl_c.93.

Abstract

A 3-day regimen of azithromycin (500 mg once daily) and a 10-day regimen of co-amoxiclav (625 mg three times daily) were compared in a double-blind study of 67 patients with acute infectious exacerbations of chronic bronchitis (AIECBs, n = 54), acute bronchitis (n = 7), or pneumonia (n = 6). In patients treated with azithromycin, satisfactory clinical responses (cure or improvement) were seen in 24/28 (86%) patients with AIECBs, 2/4 (50%) with acute bronchitis and 2/2 (100%) with pneumonia. Responses were satisfactory in 24/26 (92%), 4/4 (100%) and 4/4 (100%) patients, respectively, receiving co-amoxiclav. Streptococcus pneumoniae and Haemophilus influenzae were the commonest pathogens isolated at baseline. At the end of treatment, baseline pathogens were eradicated in 9/10 microbiologically-assessable patients treated with azithromycin and in 10/10 treated with co-amoxiclav. Adverse events related or possibly related to treatment occurred in five patients in each treatment group; the majority of these events affected the gastrointestinal system. One patient in each treatment group discontinued therapy because of adverse events. The study, therefore, demonstrates that 500 mg azithromycin administered once daily for 3 days is as efficacious and well tolerated as co-amoxiclav given three times daily for 10 days in the domiciliary treatment of adults with acute lower respiratory tract infections.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Amoxicillin / administration & dosage
  • Amoxicillin / adverse effects
  • Amoxicillin / therapeutic use
  • Amoxicillin-Potassium Clavulanate Combination
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Azithromycin / administration & dosage
  • Azithromycin / adverse effects
  • Azithromycin / therapeutic use*
  • Clavulanic Acids / administration & dosage
  • Clavulanic Acids / adverse effects
  • Clavulanic Acids / therapeutic use
  • Double-Blind Method
  • Drug Therapy, Combination / administration & dosage
  • Drug Therapy, Combination / adverse effects
  • Drug Therapy, Combination / therapeutic use*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Respiratory Tract Infections / drug therapy*
  • Respiratory Tract Infections / microbiology

Substances

  • Anti-Bacterial Agents
  • Clavulanic Acids
  • Amoxicillin-Potassium Clavulanate Combination
  • Amoxicillin
  • Azithromycin