Comparison of the efficacy and tolerability of short-course cefuroxime axetil and amoxicillin/clavulanic acid in the treatment of secondary bacterialinfections of acute bronchitis - A multicentre, randomised, double-blind clinical trial

Objective and Study Design: This multicentre, randomised, double-blind clin ical trial compared the clinical and bacteriological efficacy and safety of cefuroxime axetil and amoxicillin/clavulanic acid in the treatment of seco ndary bacterial infections of acute bronchitis (SBIAB). Patients and Methods: 312 patients with signs and symptoms of acute bronchi tis 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% o f M. catarrhalis isolates produced p-lactamase. A satisfactory clinical out come was achieved in 86% (114 of 133) and 90% (128 of 142) of the clinicall y evaluable patients treated with cefuroxime axetil or amoxicillin/clavulan ic acid, respectively (p = 0.27), at the 11- to 14-day follow-up visit. A s atisfactory bacteriological outcome was obtained in 89% (110 of 123) and 92 % (123 of 134) of bacteriologically and clinically evaluable patients treat ed with cefuroxime axetil or amoxicillin/clavulanic acid, respectively (p = 0.516), at the 11- to 14-day followup visit. Amoxicillin/clavulanic acid t reatment was associated with a greater incidence of drug-related adverse ev ents (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 eff icacy to amoxicillin/clavulanic acid 875/125mg twice daily for 10 days in t he treatment of acute bronchitis, and produces fewer drug-related adverse e vents.