The efficacy and safety of cefixime and amoxicillin/ clavulanate in the treatment of asymptomatic bacteriuria in pregnant women: a randomized, prospective, multicenter study


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The study was aimed to the evaluation of efficacy and safety of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women. A prospective, multicenter, randomized study that included 112 pregnant women with asymptomatic bacteriuria was performed. 58 women were randomized in group 1 (cefixime [suprax solutab®] 400 mg 1 time a day, 7 days), 54 women were included in group 2 (amoxicillin/clavulanate [amoksiklav®] 625 mg 3 times a day, 7 days). The average age of the patients in group 1 was 25,2±6,6; in group 2 - 26,6±5,8 years. Physical examination, evaluation of complaints, collection of data on adverse reactions, and bacteriological analysis of urine were performed after enrollment in the study at visit 2 (day 10±1) and 3 (day 35±2). Comparable effectiveness of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women was found. Eradication of the pathogen and sustained bacteriological response were observed in 94,8 and 92,7% of women treated with cefixime, and in 98,2 and 92,5 % of women treated with amoxicillin/clavulanate, respectively (P> 0,05). At the same time, the use of amoxicillin/clavulanate compared with cefixime significantly higher was followed by the development of adverse reactions (13% and 1,7; respectively; P = 0,02). Seven-day courses of cefixime at a dose 400 mg 1 time a day and amoxicillin/clavulanate at a dose of 625 mg 3 times a day are high-effective treatment regimens for asymptomatic bacteriuria in pregnant women in Russia. The use of amoxicillin/ clavulanate is significantly more often accompanied by the development of adverse reactions compared with cefixime.

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