Clinical trial NCT00292344: Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea
Official title: Rifaximin in Standard Three-Day Dosing With and Without the Antimotility Drug, Loperamide, in the Treatment of Travelers' Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Travelers' Diarrhea
Keywords: Travelers' diarrhea
rifaximin
loperamide
enterotoxigenic E. coli
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Bausch Health Americas, Inc.
First posted: 2006-02-15
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Most cases of travelers' diarrhea are caused by bacterial pathogens which respond slowly to antibiotic treatment.The study was designed to determine the value of rapidly acting loperamide (imodium) combined with curative dose of the poorly absorbed rifaximin in travelers' diarreha treatment.

Detailed description: During short-term study, adult U.S. students in Mexico (n = 310) with acute diarrhea (≥ 3 unformed stools with enteric symptoms) were enrolled in a double-blind, randomized trial wherein they were given rifaximin 200 mg three times a day for 3 days (R) (n = 102), loperamide 4 mg initially followed by 2 mg after each unformed stool not to exceed 8 mg/day for 2 days (L) (n = 104) or both drugs in the same dosage schedule (L/R) (n = 104). The major outcome parameter was time from initiation of therapy until passage of the last unformed stool before becoming well (TLUS).

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria include: IRB approval; signing of a consent form;18 years of age or older, providing of an unformed pre-treatment stool; females must be non-pregnant and not nursing.

Exclusion Criteria:

* Exclusion criteria include: diarrhea longer than 72 hours; moderate or severe dehydration, pregnancy or breast feeding, receipt of trimethoprim-sulfamethoxazole, azalide, doxycycline, or a fluoroquinolone in the past week; unstable medical condition; hypersensitivity to rifaximin or rifampin; fever (\>100.6o F) or bloody diarrhea.

Primary outcomes:
measure: The major outcome parameter was time from initiation of therapy until passage of the last unformed stool before becoming well (TLUS).
Secondary outcomes:
measure: Secondary Outcome Variables:
measure: 1. Time to passage of last unformed stool - standard definition of TLUS for antibiotics (18, 20) where wellness is declared at any time during 5 days regardless of later recurrence of continuing illness during the observation period;
measure: 2. Number of unformed stools passed during two days of therapy;
measure: 3. Number of unformed stools passed during the five days of study;
measure: 4. Improvement in diarrhea (<half the number of daily entry unformed stools in 24 hours) by 24 hours and 48 hours;
measure: 5. Treatment failure defined as: a. failure to achieve wellness during five days of study (achieve a TLUS-5 d); b. Deterioration during treatment and removed from further clinical evaluation, or, c. Occurrence of a relapse after achieving wellness during
measure: 6. Occurrence of relapse during five day surveillance (occurrence of diarrhea after having a TLUS);
measure: 7. TLUS in 48 hours - last unformed stool passed during the 48 hours that loperamide is being given (rapid symptomatic improvement);
measure: 8. Number of days of moderate or severe enteric symptoms;
measure: 9. Number of days passing any number of unformed stools plus any degree (mild, moderate or severe) of daily enteric symptoms (must have both present each day);
measure: 10. Subjects global assessment of efficacy by day of study;
measure: 11. Number of hours where schedule of activities were altered because of illness;
measure: 12. Number of hours confined to bed because of diarrhea;
measure: 13. Dropped from study due to adverse reaction;
measure: 14. Number of doses of loperamide (or loperamide placebos) taken;
measure: 15. Microbiologic eradication/failure.
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Universidad Autonoma de Guadalajara
state: Jalisco
city: Guadalajara
country: Mexico
facility: University of Arizona, Colegio Guadalajara
state: Jalisco
city: Guadalajara
country: Mexico
facility: University of San Diego at Iteso
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Clinica Londres Morelos
state: Morelos
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Herbert L. DuPont, MD
role: PRINCIPAL_INVESTIGATOR
References: