Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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This study has been withdrawn prior to enrollment.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 Study withdrawn from IRB consideration.)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

April 3, 2009
October 5, 2009
June 2009
June 2009   (final data collection date for primary outcome measure)
Time from beginning therapy to passage of last unformed stool [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00875875 on ClinicalTrials.gov Archive Site
Side effects as reported by the subjects on diaries [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Single Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea
Single Daily Dose Rifaximin vs. Standard Thrice Daily Dosing for the 3-Day Treatment of Travelers' Diarrhea

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Travelers' Diarrhea
Drug: Rifaximin
Rifaximin 200 mg TID for 3 days OR Rifaximin 600 mg Daily for 3 days
Other Name: Xifaxin
  • Active Comparator: 1
    This is the approved treatment regimen for travelers' diarrhea (600 mg)
    Intervention: Drug: Rifaximin
  • Active Comparator: 2
    This is the same dose as the standard dose, given once daily (200 mg)
    Intervention: Drug: Rifaximin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
300
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00875875
Ericsson-001
No
Charles D. Ericsson, MD Professor of Medicine Head, Clinical Infectious Diseases, University of Texas Medical School at Houston
The University of Texas Health Science Center, Houston
Not Provided
Principal Investigator: Charles D Ericsson, MD University of Texas Medical School at Houston
The University of Texas Health Science Center, Houston
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP