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A RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY OF RIFAXIMIN COMPARED WITH PLACEBO AND WITH CIPROFLOXACIN IN THE TREATMENT OF TRAVELERS’ DIARRHEA

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.

Received October 21, 2005. Accepted for publication February 1, 2006.

Disclosure: Authors Haake and Taylor are currently employed by Salix Pharmaceuticals, US marketer of rifaximin. Authors DuPont, Ericsson, and Steffen serve as consultants to Salix Pharmaceuticals. Dr. Jiang has received grants from Salix Pharmaceuticals. The research described in this manuscript was funded by Salix Pharmaceuticals, Inc.

^* Address correspondence to David N. Taylor, 1700 Perimeter Park Dr., Morrisville, NC 27560. E-mail: david.taylor{at}salix.com

Authors’ addresses: David N. Taylor, 1700 Perimeter Park Dr., Morrisville, NC 27560, E-mail: david.taylor{at}salix.com. A. Louis Bourgeois, Department of International Health, Johns Hopkins University, Bloomberg School of Public Health, 624 N. Broadway, Room 20, Baltimore, MD 21205, E-mail: abourgeo{at}jhsph.edu. Charles D. Ericsson, The University of Texas Medical School at Houston, Department of Internal Medicine, Division of Infectious Diseases, 6431 Fannin, Suite JFB 1.728, Houston, TX 77030, E-mail: Charles.D.Ericsson{at}uth.tmc.edu. Robert Steffen, Division of Communicable Diseases, Institute of Social and Preventive Medicine of the University of Zurich, Zurich, Switzerland, E-mail: roste{at}ifspm.unizh.ch. Zhi-Dong Jiang, Enteric Infectious Disease Research Center, The University of Texas, Houston, TX 77030, E-mail: Zjiang{at}sph.uth.tmc.edu. Jane Halpern, Johns Hopkins University, 624 N. Broadway, Room 20, Baltimore, MD 21205, E-mail: jhalpern{at}towson.edu. Robert Haake, 1700 Perimeter Park Dr., Morrisville, NC 27560, E-mail: robert.haake{at}salix.com. Herbert L. Du-Pont, Internal Medicine, St. Luke’s Episcopal Hospital, 6720 Bertner Ave., Room P-153, Mail Code: 1-164, Houston, TX 77030, E-mail: hdupont{at}sleh.com. Rifaximin Study Group: Santanu Chatterjee (Calcutta, India), Dilip Motghare (Goa, India), Edwin Asturias (Antigua, Guatemala), Francisco Martinez Sandoval (Guadalajara, Mexico), Jaime Belkind-Gerson (Cuernavaca, Mexico), Alejandro Rios Ramirez (Puerto Vallarta, Mexico), and Eduardo Gotuzzo (Lima, Peru).

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