Single Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea

Travelers' Diarrhea Clinical Trial

— Rifaximin 600  

Official title:

Single Daily Dose Rifaximin vs. Standard Thrice Daily Dosing for the 3-Day Treatment of Travelers' Diarrhea

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00875875
• Other study ID #: Ericsson-001
• Status: Withdrawn
• Phase: Phase 4
• First received: April 3, 2009
• Last updated: June 8, 2015
• Start date: June 2009
• Est. completion date: June 2009

Study information

• Verified date: June 2015
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• Dysentery
• Travelers' Diarrhea

Intervention

Drug:
• Rifaximin
Rifaximin 200 mg TID for 3 days OR Rifaximin 600 mg Daily for 3 days

Locations

Country	Name	City	State
Mexico	Enteric Disease Clinic	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from beginning therapy to passage of last unformed stool		5 days	No
Secondary	Side effects as reported by the subjects on diaries		5 days	Yes