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

DAVID N. TAYLOR Department of International Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Center for Infectious Diseases, The University of Texas, Houston School of Public Health and Medical School, Houston, Texas; Division of Communicable Diseases, Institute of Social and Preventive Medicine of the University of Zurich, Zurich, Switzerland; Enteric Infectious Disease Research Center, The University of Texas, Houston, Texas; Salix Pharmaceuticals, Inc., Morrisville, North Carolina; School of Public Health, University of Texas, Houston, Texas, and St. Luke’s Episcopal Hospital, Baylor College of Medicine, Houston, Texas

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A. LOUIS BOURGEOIS Department of International Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Center for Infectious Diseases, The University of Texas, Houston School of Public Health and Medical School, Houston, Texas; Division of Communicable Diseases, Institute of Social and Preventive Medicine of the University of Zurich, Zurich, Switzerland; Enteric Infectious Disease Research Center, The University of Texas, Houston, Texas; Salix Pharmaceuticals, Inc., Morrisville, North Carolina; School of Public Health, University of Texas, Houston, Texas, and St. Luke’s Episcopal Hospital, Baylor College of Medicine, Houston, Texas

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CHARLES D. ERICSSON Department of International Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Center for Infectious Diseases, The University of Texas, Houston School of Public Health and Medical School, Houston, Texas; Division of Communicable Diseases, Institute of Social and Preventive Medicine of the University of Zurich, Zurich, Switzerland; Enteric Infectious Disease Research Center, The University of Texas, Houston, Texas; Salix Pharmaceuticals, Inc., Morrisville, North Carolina; School of Public Health, University of Texas, Houston, Texas, and St. Luke’s Episcopal Hospital, Baylor College of Medicine, Houston, Texas

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ROBERT STEFFEN Department of International Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Center for Infectious Diseases, The University of Texas, Houston School of Public Health and Medical School, Houston, Texas; Division of Communicable Diseases, Institute of Social and Preventive Medicine of the University of Zurich, Zurich, Switzerland; Enteric Infectious Disease Research Center, The University of Texas, Houston, Texas; Salix Pharmaceuticals, Inc., Morrisville, North Carolina; School of Public Health, University of Texas, Houston, Texas, and St. Luke’s Episcopal Hospital, Baylor College of Medicine, Houston, Texas

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ZHI-DONG JIANG Department of International Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Center for Infectious Diseases, The University of Texas, Houston School of Public Health and Medical School, Houston, Texas; Division of Communicable Diseases, Institute of Social and Preventive Medicine of the University of Zurich, Zurich, Switzerland; Enteric Infectious Disease Research Center, The University of Texas, Houston, Texas; Salix Pharmaceuticals, Inc., Morrisville, North Carolina; School of Public Health, University of Texas, Houston, Texas, and St. Luke’s Episcopal Hospital, Baylor College of Medicine, Houston, Texas

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JANE HALPERN Department of International Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Center for Infectious Diseases, The University of Texas, Houston School of Public Health and Medical School, Houston, Texas; Division of Communicable Diseases, Institute of Social and Preventive Medicine of the University of Zurich, Zurich, Switzerland; Enteric Infectious Disease Research Center, The University of Texas, Houston, Texas; Salix Pharmaceuticals, Inc., Morrisville, North Carolina; School of Public Health, University of Texas, Houston, Texas, and St. Luke’s Episcopal Hospital, Baylor College of Medicine, Houston, Texas

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ROBERT HAAKE Department of International Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Center for Infectious Diseases, The University of Texas, Houston School of Public Health and Medical School, Houston, Texas; Division of Communicable Diseases, Institute of Social and Preventive Medicine of the University of Zurich, Zurich, Switzerland; Enteric Infectious Disease Research Center, The University of Texas, Houston, Texas; Salix Pharmaceuticals, Inc., Morrisville, North Carolina; School of Public Health, University of Texas, Houston, Texas, and St. Luke’s Episcopal Hospital, Baylor College of Medicine, Houston, Texas

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HERBERT L. DUPONT Department of International Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Center for Infectious Diseases, The University of Texas, Houston School of Public Health and Medical School, Houston, Texas; Division of Communicable Diseases, Institute of Social and Preventive Medicine of the University of Zurich, Zurich, Switzerland; Enteric Infectious Disease Research Center, The University of Texas, Houston, Texas; Salix Pharmaceuticals, Inc., Morrisville, North Carolina; School of Public Health, University of Texas, Houston, Texas, and St. Luke’s Episcopal Hospital, Baylor College of Medicine, Houston, Texas

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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.

Author Notes

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