Rifaximin Versus Placebo in the Prevention of Travelers' Diarrhea - Full Text View

Sponsors and Collaborators:	DuPont, Hurbert L., MD Salix Pharmaceuticals The University of Texas Health Science Center, Houston
Information provided by:	DuPont, Hurbert L., MD
ClinicalTrials.gov Identifier:	NCT00098384

Purpose

The purpose of this study is to evaluate the effectiveness of poorly absorbed rifaximin in the prevention of travelers' diarrhea among U.S. college students in Mexico for five weeks.

Condition	Intervention	Phase
Diarrhea	Drug: rifaximin	Phase II

MedlinePlus related topics: Diarrhea

Drug Information available for: Rifaximin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double-Blind, Single Center, Comparative Dose Ranging Study of Rifaximin Vs. Placebo in the Prevention of Travelers' Diarrhea Due to Enteropathogenic Bacteria

Further study details as provided by DuPont, Hurbert L., MD:

Primary Outcome Measures:

Occurrence of diarrhea, defined as passage of >2 unformed stools/24 hr plus one or more signs or symptoms of enteric infection

Secondary Outcome Measures:

Occurrence of mild diarrhea (1 or 2 unformed stools/24 hr plus a sign or symptom)
Treatment failure (not well in five days)
Occurrence of moderate to severe abdominal pain/cramps or intestinal gas related symptoms

Estimated Enrollment:	220
Study Start Date:	June 2003
Estimated Study Completion Date:	September 2003

Detailed Description:

This is an investigator-initiated proposal wherein 220 male and female subjects >17 years of age from industrialized regions were randomized to receive a poorly absorbed antibiotic, rifaximin, in one of three doses at mealtime (when they are exposed to diarrhea-causing bacteria), 200 mg once a day, 200 mg twice a day or 200 mg three times a day versus a placebo starting on arrival (within the first 72 hours) to Mexico and continuing for two weeks with diaries of symptoms recorded for three weeks. Adverse events in the subjects were followed for five weeks. If mild diarrhea (1 or 2 unformed stools/24 hours plus an enteric symptom) or diarrheal illness (>2 unformed stools/24 hours plus an enteric symptom) developed, subjects provided a stool sample to determine cause of illness. Forty subjects provided stool samples after 7 days and 14 days treatment to see if their intestinal bacterial flora had developed resistance to rifaximin and to see the level of drug achieved. Stool samples from these forty subjects were studied for enteric pathogens to look for asymptomatic infection during the period of prophylaxis. The stool samples collected were initially processed in our enteric laboratories in Guadalajara, Mexico. Specialized tests such as studies of toxigenicity for enterotoxigenic E. coli and enteroadherence for enteroaggregative E. coli were done in Houston.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

An Investigational Review Board approved, written informed consent is appropriately witnessed, signed and dated prior to any study-related activities
Male or female subjects 18 years of age or older
Able to read and understand English
Enrolled and started on prophylaxis within 72 hours of arrival in Mexico
If the subject is female, only women with non-childbearing potential or those who are not pregnant will be eligible. Urine pregnancy tests will be performed on those women who question their pregnancy status. Women on the study are required to employ a reliable method of contraception while taking medication. Forms of acceptable contraception include:
- Double barrier method of contraception.
- Oral birth control pills for at least two cycles before enrollment and continuing during therapy – subjects will be told they should use a barrier contraception method during the study as well.
- Norplant inserted at least one month before enrollment.
- An intrauterine device inserted by a qualified clinician.
- Medroxyprogesterone acetate for a minimum of one month before study and administered for one month following study completion.
- An approved birth control patch for at least two cycles before enrollment and continuing during therapy. OR
- Complete abstinence from intercourse for the two weeks of medication.

Exclusion Criteria:

Acute diarrhea (criteria for travelers’ diarrhea above) within the past week
Diarrhea developing within 24 hours of study enrollment
In Mexico for more than 72 hours
Receipt of one of the following classes of drugs: fluoroquinolone (any drug in class), macrolide or azalide or trimethoprim-sulfamethoxazole within the past week or during the three week study
Receipt of other medication to decrease the occurrence of diarrhea (e.g. bismuth subsalicylate or lactobacillus preparations)
For females, pregnancy or breast feeding during the three week study
Receipt of antidiarrheal medication (loperamide, bismuth subsalicylate, kaopectate) within 24 hours of enrollment
Hypersensitivity to rifaximin
Unstable medical condition including chronic renal failure and insulin dependent diabetes.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098384

Locations

Mexico, Jalisco
Universidad Autonoma de Guadalajara
Guadalajara, Jalisco, Mexico

Sponsors and Collaborators

DuPont, Hurbert L., MD

Salix Pharmaceuticals

The University of Texas Health Science Center, Houston

More Information

Publications of Results:

DuPont HL, Jiang ZD, Okhuysen PC, Ericsson CD, de la Cabada FJ, Ke S, DuPont MW, Martinez-Sandoval F. A randomized, double-blind, placebo-controlled trial of rifaximin to prevent travelers' diarrhea. Ann Intern Med. 2005 May 17;142(10):805-12. Erratum in: Ann Intern Med. 2005 Aug 2;143(3):239. Summary for patients in: Ann Intern Med. 2005 May 17;142(10):I30.

Other Publications:

DuPont HL, Jiang ZD, Ericsson CD, Adachi JA, Mathewson JJ, DuPont MW, Palazzini E, Riopel LM, Ashley D, Martinez-Sandoval F. Rifaximin versus ciprofloxacin for the treatment of traveler's diarrhea: a randomized, double-blind clinical trial. Clin Infect Dis. 2001 Dec 1;33(11):1807-15. Epub 2001 Oct 23.

DuPont HL, Ericsson CD. Prevention and treatment of traveler's diarrhea. N Engl J Med. 1993 Jun 24;328(25):1821-7. Review. No abstract available.

Study ID Numbers:	PR 03
Study First Received:	December 7, 2004
Last Updated:	May 8, 2006
ClinicalTrials.gov Identifier:	NCT00098384
Health Authority:	United States: Food and Drug Administration

Keywords provided by DuPont, Hurbert L., MD:

Travelers’ diarrhea
rifaximin
prophylaxis
enterotoxigenic E. coli

Study placed in the following topic categories:

Signs and Symptoms
Digestive System Diseases
Diarrhea
Signs and Symptoms, Digestive
Gastrointestinal Diseases

Dysentery
Rifaximin
Intestinal Diseases
Gastroenteritis

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009