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A Randomized, Double-Blind, Placebo-Controlled Trial of Rifaximin To Prevent Travelers' Diarrhea

Herbert L. DuPont, MD; Zhi-Dong Jiang, PhD; Pablo C. Okhuysen, MD; Charles D. Ericsson, MD; Francisco Javier de la Cabada, MD; Shi Ke, MD; Margaret W. DuPont, MA; and Francisco Martinez-Sandoval, MD, PhD
[+] Article and Author Information

From the University of Texas–Houston, Baylor College of Medicine, St. Luke's Episcopal Hospital, and M.D. Anderson Cancer Center, Houston, Texas; and Hospital General de Occidente and Universidad Autonoma de Guadalajara, Guadalajara, Mexico.


Trial NCT00098384.

Presented at Digestive Diseases Week, New Orleans, Louisiana, 16 May 2004.

Acknowledgments: The authors acknowledge the valuable contributions of several colleagues. The field research team was composed of Dorothy Ruelas, RN; Sylvia Vaca, RN; Carmen Pulido; Mathew Cherno; David Hamilton; Elizabeth Juarez; Shelby Melton; Sean Pawlowski; and Courtney Ramirez. Directors of the participating schools at the Guadalajara Summer Programs of the University of Arizona and the University of San Diego were Drs. Macario Saldate and Carl Jubran. Robert Haake and Mary Sarah Baraniuk provided statistical advice on the study, and Dr. David N. Taylor provided editorial help.

Grant Support: By Salix Pharmaceuticals; the Vaccine and Treatment Evaluation Unit Enteric Challenge Studies (NO1-AI-25465); and Public Health Service grant DK 56338, which funds the Texas Gulf Coast Digestive Diseases Center.

Potential Financial Conflicts of Interest: Consultancies: H.L. DuPont (Salix Pharmaceuticals), P.C. Okhuysen (Abbott Laboratories, Aventis, Bristol-Myers Squibb, Cubist, Merck, Pfizer, Salix Pharmaceuticals, Trimeris), C.D. Ericsson (Salix Pharmaceuticals); Honoraria: H.L. DuPont (Salix Pharmaceuticals), P.C. Okhuysen (Abbott Laboratories, Aventis, Bristol-Myers Squibb, Cubist, Merck, Pfizer, Salix Pharmaceuticals, Trimeris), C.D. Ericsson (Salix Pharmaceuticals); Grants received: H.L. DuPont (Salix Pharmaceuticals), C.D. Ericsson (Salix Pharmaceuticals).

Requests for Single Reprints: Herbert L. DuPont, MD, 6720 Bertner Avenue, MC 1-164, Houston, TX 77030; e-mail, hdupont@sleh.com.

Current Author Addresses: Dr. DuPont: 6720 Bertner Avenue, MC 1-164, Houston, TX 77030.

Dr. Jiang: University of Texas–Houston School of Public Health, 1200 Herman Pressler, Houston, TX 77030.

Dr. Okhuysen: Division of Infectious Diseases, University of Texas– Houston Health Science Center, 6431 Fannin Street, JFB 1.728, Houston, TX 77030.

Dr. Ericsson: University of Texas Medical School at Houston, 6431 Fannin Street, Houston, TX 77050.

Dr. de la Cabada: Avenida "C", 630K, Col. Seattle Zapopan, Jalisco CP 45150, Mexico.

Dr. Ke: University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030.

Ms. DuPont: 1111 Herman Drive, 19F, Houston, TX 77004.

Dr. Martinez-Sandoval: Universidad Autonoma de Guadalajara, Apartado Postal 1-440, Guadalajara, Jalisco 45110, Mexico.

Author Contributions: Conception and design: H.L. DuPont, Z.-D. Jiang, C.D. Ericsson, S. Ke, F. Martinez-Sandoval.

Analysis and interpretation of the data: H.L DuPont, Z.-D. Jiang, P.C. Okhuysen, C.D. Ericsson, S. Ke.

Drafting of the article: H.L. DuPont.

Critical revision of the article for important intellectual content: H.L. DuPont, Z.-D. Jiang, P.C. Okhuysen, C.D. Ericsson, S. Ke.

Final approval of the article: H.L. DuPont, Z.-D. Jiang.

Provision of study materials or patients: H.L. DuPont, P.C. Okhuysen, C.D. Ericsson, F.J. de la Cabada, F. Martinez-Sandoval.

Statistical expertise: H.L. DuPont, Z.-D. Jiang, S. Ke.

Obtaining of funding: H.L. DuPont.

Administrative, technical, or logistic support: H.L. DuPont, Z.-D. Jiang, P.C. Okhuysen, C.D. Ericsson, M.W. DuPont.

Collection and assembly of data: H.L. DuPont, Z.-D. Jiang, P.C. Okhuysen, F.J. de la Cabada, M.W. DuPont, F. Martinez-Sandoval.


Ann Intern Med. 2005;142(10):805-812. doi:10.7326/0003-4819-142-10-200505170-00005
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This randomized, double-blind, placebo-controlled study was investigator-initiated and was filed with the U.S. Food and Drug Administration. We used the CONSORT (Con solidated S tandards o f R eporting T rials) approach (20) to report our results. The Committees for the Protection of Human Subjects at the University of Texas—Houston Health Science Center and the University of San Diego approved the study protocol.

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Figures

Grahic Jump Location
Figure 1.
Probability of not experiencing diarrhea during the first 2 weeks in Mexico in participants taking 200 mg of rifaximin once daily (QD), twice daily (BID), or 3 times daily (TID) compared with placebo.

 < 0.001 for each study group compared with placebo; after Bonferroni adjustment for multiple comparisons of subgroups,  < 0.005 for each study group compared with placebo.

Grahic Jump Location
Grahic Jump Location
Figure 2.
Probability of not experiencing mild diarrhea during the first 2 weeks in Mexico in participants taking rifaximin (3 groups combined) compared with placebo.

 = 0.02.

Grahic Jump Location

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Summary for Patients

Can a New Antibiotic Safely Prevent Travelers' Diarrhea?

The summary below is from the full report titled “A Randomized, Double-Blind, Placebo-Controlled Trial of Rifaximin To Prevent Travelers' Diarrhea.” It is in the 17 May 2005 issue of Annals of Internal Medicine (volume 142, pages 805-812). The authors are H.L. DuPont, Z.-D. Jiang, P.C. Okhuysen, C.D. Ericsson, F. Javier de la Cabada, S. Ke, M.W. DuPont, and F. Martinez-Sandoval.

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