Single Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea

NCT ID: NCT00875875

Last Updated: 2015-06-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2009-06-30

Brief Summary

The study will compare durations of diarrhea among subjects who report to clinic for treatment and who receive either:

1. standard rifaximin therapy at a dose of 200 mg three times a day for 3 days, OR

2. a single 600 mg dose of rifaximin daily for 3 days.

Conditions

Travelers' Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

This is the approved treatment regimen for travelers' diarrhea (600 mg)

Group Type: ACTIVE_COMPARATOR

Rifaximin

Intervention Type: DRUG

Rifaximin 200 mg TID for 3 days OR Rifaximin 600 mg Daily for 3 days

2

This is the same dose as the standard dose, given once daily (200 mg)

Group Type: ACTIVE_COMPARATOR

Rifaximin

Intervention Type: DRUG

Rifaximin 200 mg TID for 3 days OR Rifaximin 600 mg Daily for 3 days

Interventions

Rifaximin

Rifaximin 200 mg TID for 3 days OR Rifaximin 600 mg Daily for 3 days

Intervention Type: DRUG

Other Intervention Names

Xifaxin

Eligibility Criteria

Inclusion Criteria

• passage of 3 or more unformed stools in 24 hours plus an additional symptom of enteric disease such as abdominal cramps, nausea, vomiting, or fever; and investigator verification that an unformed stool has been submitted.
• is > 18 years of age
• has diarrhea (at least three unformed stools in 24 hrs) plus at least one additional sign or symptom of enteric illness
• has acute diarrhea less than 1 week's duration
• willingness to provide a diarrhea stool sample
• willingness to keep a daily diary for 5 days
• signed informed consent

Exclusion Criteria

• fever or bloody diarrhea
• has taken predictably effective antibiotics in the past week (e.g. quinolones, TMP/SMX, azalide or doxycycline)
• is pregnant now, likely to become pregnant, or breast-feeding
• has duration of diarrhea of greater than 1 weeks
• is allergic to Rifampin or Rifaximin
• has a history of significant underlying enteric, pulmonary, cardiac, renal disease, or any CNS disorder
• is more than moderately dehydrated

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Charles D Ericsson

◦Professor and Dr. and Mrs. Carl V. Vartian Professor in Infectious Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles D Ericsson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Medical School at Houston

Locations

Enteric Disease Clinic

Guadalajara, Jalisco, Mexico

Countries

Mexico

Other Identifiers

Ericsson-001

Identifier Type: -

Identifier Source: org_study_id