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Clinical Drug Investigation

, Volume 18, Issue 5, pp 335–344 | Cite as

Comparison of the Efficacy and Tolerability of Short-Course Cefuroxime Axetil and Amoxicillin/Clavulanic Acid in the Treatment of Secondary Bacterial Infections of Acute Bronchitis

A Multicentre, Randomised, Double-Blind Clinical Trial
  • Dan C. Henry
  • Gary E. Ruoff
  • Michael Noonan
  • C. Andrew DeAbate
  • Anthony D. Puopolo
  • Robert Bettis
  • Scott Burroughs
  • Margaret Cobb
  • H. Preston HolleyJr
Clinical Use

Abstract

Objective and Study Design: This multicentre, randomised, double-blind clinical trial compared the clinical and bacteriological efficacy and safety of cefuroxime axetil and amoxicillin/clavulanic acid in the treatment of secondary bacterial infections of acute bronchitis (SBIAB).

Patients and Methods: 312 patients with signs and symptoms of acute bronchitis were enrolled at 16 centres and randomised to receive either 5 days of treatment with cefuroxime axetil 250mg twice daily (n = 156) or 10 days of treatment with amoxicillin/clavulanic acid 875/125mg twice daily (n = 156). Patients were assessed once during treatment (3 to 5 days) and twice post-treatment (1 to 4 days and 11 to 14 days post-treatment).

Results: Organisms were isolated from pretreatment sputum specimens of 294 of 312 (94%) patients, common pathogens being Haemophilus parainfluenzae, H. influenzae, Moraxella catarrhalis and Streptococcus pneumoniae (39, 23, 9 and 8% of isolates, respectively). 33% of H. influenzae isolates and 88% of M. catarrhalis isolates produced β-lactamase. A satisfactory clinical outcome was achieved in 86% (114 of 133) and 90% (128 of 142) of the clinically evaluable patients treated with cefuroxime axetil or amoxicillin/clavulanic acid, respectively (p = 0.27), at the 11-to 14-day follow-up visit. A satisfactory bacteriological outcome was obtained in 89% (110 of 123) and 92% (123 of 134) of bacteriologically and clinically evaluable patients treated with cefuroxime axetil or amoxicillin/clavulanic acid, respectively (p = 0.516), at the 11-to 14-day follow-up visit. Amoxicillin/clavulanic acid treatment was associated with a greater incidence of drug-related adverse events (32 vs 12%, p < 0.001), particularly gastrointestinal adverse events (23 vs 4%, p < 0.001), than was cefuroxime axetil treatment.

Conclusions: Cefuroxime axetil 250mg twice daily for 5 days has similar efficacy to amoxicillin/clavulanic acid 875/125mg twice daily for 10 days in the treatment of acute bronchitis, and produces fewer drug-related adverse events.

Keywords

Adis International Limited Cefuroxime Clavulanic Acid Clin Drug Invest Acute Bronchitis 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Adis International Limited 1999

Authors and Affiliations

  • Dan C. Henry
    • 1
  • Gary E. Ruoff
    • 2
  • Michael Noonan
    • 3
  • C. Andrew DeAbate
    • 4
  • Anthony D. Puopolo
    • 5
  • Robert Bettis
    • 6
  • Scott Burroughs
    • 7
  • Margaret Cobb
    • 7
  • H. Preston HolleyJr
    • 7
  1. 1.Clinical Research Advantage Foothill Family ClinicSalt Lake CityUSA
  2. 2.Westside Family Medical Center, PCKalamazooUSA
  3. 3.Allergy Associates Research CenterPortlandUSA
  4. 4.Medical Research CentersNew OrleansUSA
  5. 5.Milford Emergency Associates, Inc.MilfordUSA
  6. 6.Edmonds Family Medicine ClinicEdmondsUSA
  7. 7.Infectious Diseases DepartmentGlaxo Wellcome Inc.Research Triangle ParkUSA

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