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A randomized, double-blind, multicenter study of rifaximin compared with placebo and with ciprofloxacin in the treatment of travelers' diarrhea


Taylor, D N; Bourgeois, A L; Ericsson, C D; Steffen, R; Jiang, Z D; Halpern, J; Haake, R; Dupont, H L (2006). A randomized, double-blind, multicenter study of rifaximin compared with placebo and with ciprofloxacin in the treatment of travelers' diarrhea. The American Journal of Tropical Medicine and Hygiene, 74(6):1060-1066.

Abstract

Rifaximin was compared with placebo and ciprofloxacin for treatment of travelers' diarrhea in a randomized, double-blind clinical trial. Adult travelers (N = 399) consulting travel clinics in Mexico, Guatemala, and India were randomized to receive rifaximin 200 mg three times a day, ciprofloxacin (500 mg two times a day and placebo once a day), or placebo three times a day for 3 days. Patients recorded in daily diaries the time and consistency of each stool and documented symptoms for 5 days after treatment. Stool samples were collected for microbiologic evaluations before and after treatment. The median time to last unformed stool (TLUS) in the rifaximin group (32.0 hours) was less than one half that in the placebo group (65.5 hours; P = 0.001; risk ratio 1.6; 95% confidence interval 1.2, 2.2; primary efficacy endpoint). The median TLUS in the ciprofloxacin group was 28.8 hours (P = 0.0003 versus placebo; P = 0.35 versus rifaximin). Rifaximin was less effective than ciprofloxacin for invasive intestinal bacterial pathogens. Oral rifaximin is a safe and effective treatment of travelers' diarrhea caused by noninvasive pathogens.

Abstract

Rifaximin was compared with placebo and ciprofloxacin for treatment of travelers' diarrhea in a randomized, double-blind clinical trial. Adult travelers (N = 399) consulting travel clinics in Mexico, Guatemala, and India were randomized to receive rifaximin 200 mg three times a day, ciprofloxacin (500 mg two times a day and placebo once a day), or placebo three times a day for 3 days. Patients recorded in daily diaries the time and consistency of each stool and documented symptoms for 5 days after treatment. Stool samples were collected for microbiologic evaluations before and after treatment. The median time to last unformed stool (TLUS) in the rifaximin group (32.0 hours) was less than one half that in the placebo group (65.5 hours; P = 0.001; risk ratio 1.6; 95% confidence interval 1.2, 2.2; primary efficacy endpoint). The median TLUS in the ciprofloxacin group was 28.8 hours (P = 0.0003 versus placebo; P = 0.35 versus rifaximin). Rifaximin was less effective than ciprofloxacin for invasive intestinal bacterial pathogens. Oral rifaximin is a safe and effective treatment of travelers' diarrhea caused by noninvasive pathogens.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > Epidemiology, Biostatistics and Prevention Institute (EBPI)
Dewey Decimal Classification:610 Medicine & health
Date:2006
Deposited On:25 May 2009 05:27
Last Modified:06 Dec 2017 19:40
Publisher:American Society of Tropical Medicine and Hygiene
ISSN:0002-9637
PubMed ID:16760520

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