Single Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea - Full Text View

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

This study is not yet open for participant recruitment.

Verified by The University of Texas Health Science Center, Houston, April 2009

First Received: April 3, 2009 No Changes Posted

Sponsored by:	The University of Texas Health Science Center, Houston
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00875875

Purpose

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

standard rifaximin therapy at a dose of 200 mg three times a day for 3 days, OR
a single 600 mg dose of rifaximin daily for 3 days.

Condition	Intervention	Phase
Travelers' Diarrhea	Drug: Rifaximin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Bio-equivalence Study
Official Title:	Single Daily Dose Rifaximin vs. Standard Thrice Daily Dosing for the 3-Day Treatment of Travelers' Diarrhea

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea Giardia Infections

Drug Information available for: Rifaximin

U.S. FDA Resources

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:	September 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Active Comparator 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

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

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

Contacts

Contact: Charles D Ericsson, MD	713-500-6732	charles.d.ericsson@uth.tmc.edu
Contact: Herbert L DuPont, MD	832-355-4122	hdupont@sleh.com

Locations

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

Keywords provided by The University of Texas Health Science Center, Houston:

Diarrhea, travelers
Acute travelers' diarrhea

Study placed in the following topic categories:

Anti-Infective Agents
Protozoan Infections
Diarrhea
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Giardiasis
Intestinal Diseases

Signs and Symptoms
Digestive System Diseases
Dysentery
Parasitic Diseases
Rifaximin
Intestinal Diseases, Parasitic
Gastroenteritis

Additional relevant MeSH terms:

Anti-Infective Agents
Protozoan Infections
Diarrhea
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Gastrointestinal Agents
Mastigophora Infections
Giardiasis
Intestinal Diseases
Pharmacologic Actions

Signs and Symptoms
Digestive System Diseases
Dysentery
Therapeutic Uses
Rifaximin
Parasitic Diseases
Sarcomastigophora Infections
Intestinal Diseases, Parasitic
Gastroenteritis

ClinicalTrials.gov processed this record on September 11, 2009