Single Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea (Rifaximin 600)

This study has been withdrawn prior to enrollment.
(No study population in Mexico (H1N1). Study withdrawn from IRB consideration.)
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00875875
First received: April 3, 2009
Last updated: October 5, 2009
Last verified: October 2009
  Purpose

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.

Condition Intervention Phase
Travelers' Diarrhea
Drug: Rifaximin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Daily Dose Rifaximin vs. Standard Thrice Daily Dosing for the 3-Day Treatment of Travelers' Diarrhea

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Time from beginning therapy to passage of last unformed stool [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effects as reported by the subjects on diaries [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: June 2009
Estimated Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
This is the approved treatment regimen for travelers' diarrhea (600 mg)
Drug: Rifaximin
Rifaximin 200 mg TID for 3 days OR Rifaximin 600 mg Daily for 3 days
Other Name: Xifaxin
Active Comparator: 2
This is the same dose as the standard dose, given once daily (200 mg)
Drug: Rifaximin
Rifaximin 200 mg TID for 3 days OR Rifaximin 600 mg Daily for 3 days
Other Name: Xifaxin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875875

Locations
Mexico
Enteric Disease Clinic
Guadalajara, Jalisco, Mexico
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Charles D Ericsson, MD University of Texas Medical School at Houston
  More Information

No publications provided

Responsible Party: Charles D. Ericsson, MD Professor of Medicine Head, Clinical Infectious Diseases, University of Texas Medical School at Houston
ClinicalTrials.gov Identifier: NCT00875875     History of Changes
Other Study ID Numbers: Ericsson-001
Study First Received: April 3, 2009
Last Updated: October 5, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Diarrhea, travelers
Acute travelers' diarrhea

Additional relevant MeSH terms:
Diarrhea
Dysentery
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Rifaximin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 21, 2014