Rifaximin Versus Placebo in the Prevention of Travelers' Diarrhea

NCT00098384 | Completed Phase 2

• 1 other identifier: PR 03
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diarrhea

Keywords

Travelers' diarrhea; rifaximin; prophylaxis; enterotoxigenic E. coli

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• 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

Interventions

rifaximin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DuPont, Hurbert L., MD: lead
• Bausch Health Americas, Inc.: collaborator
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

Universidad Autonoma de Guadalajara

Guadalajara, Jalisco, Mexico

Location

Related Publications (3)

• 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. doi: 10.1086/323814. Epub 2001 Oct 23.

  PMID: 11692292 BACKGROUND

• DuPont HL, Ericsson CD. Prevention and treatment of traveler's diarrhea. N Engl J Med. 1993 Jun 24;328(25):1821-7. doi: 10.1056/NEJM199306243282507. No abstract available.

  PMID: 8502272 BACKGROUND

• 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. doi: 10.7326/0003-4819-142-10-200505170-00005.

  PMID: 15897530 RESULT

MeSH Terms

Conditions

Diarrhea

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: December 7, 2004
• First Posted: December 8, 2004
• Study Start: June 1, 2003
• Study Completion: September 1, 2003
• Last Updated: May 9, 2006

Record last verified: 2004-12

Locations

ME (1)