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
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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.
KeywordsAdis International Limited Cefuroxime Clavulanic Acid Clin Drug Invest Acute Bronchitis
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- 1.Hueston WJ, Mainous AG, 3rd. Acute bronchitis. Am Fam Phys 1998; 57: 1270–6, 1281-72Google Scholar
- 2.Gleckman R. Acute bronchitis. In: Rakel R, editor. Conn’s current therapy. Philadelphia: WB Saunders Co., 1998Google Scholar
- 6.Doern GV, Brueggemann AB, Pierce G, et al. Prevalence of antimicrobial resistance among 723 outpatient clinical isolates of Moraxella catarrhalis in the United States in 1994 and 1995: results of a 30-center national surveillance study. Antimicrob Agents Chemother 1996; 40: 2884–6PubMedGoogle Scholar
- 7.Doern GV, Brueggemann AB, Pierce G, et al. Antibiotic resistance among clinical isolates of Haemophilus influenzae in the United States in 1994 and 1995 and detection of beta-lactamase-positive strains resistant to amoxicillin-clavulanate: results of a national multicenter surveillance study. Antimicrob Agents Chemother 1997; 41: 292–7PubMedGoogle Scholar
- 8.Doern GV, Brueggemann A, Holley Jr HP, et al. Antimicrobial resistance of Streptococcus pneumoniae recovered from outpatients in the United States during the winter months of 1994 to 1995: results of a 30-center national surveillance study. Antimicrob Agents Chemother 1996; 40: 1208–3PubMedGoogle Scholar
- 11.NCCLS. Methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically. 4th ed. Approved Standard M7-A4 (ISBN 1-56238-309-4). Wayne, PA: National Committee for Clinical Laboratory Standards, 1997Google Scholar