Single Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea

NCT00875875 | Withdrawn Phase 4

• 1 other identifier: Ericsson-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Travelers' Diarrhea

Keywords

Diarrhea, travelers; Acute travelers' diarrhea

Outcome Measures

Primary Outcomes (1)

• Time from beginning therapy to passage of last unformed stool

  5 days

Secondary Outcomes (1)

• Side effects as reported by the subjects on diaries

  5 days

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: Rifaximin

2

ACTIVE COMPARATOR

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

Drug: Rifaximin

Interventions

Rifaximin DRUG

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

Also known as: Xifaxin

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Enteric Disease Clinic

Guadalajara, Jalisco, Mexico

Location

MeSH Terms

Conditions

Diarrhea

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Charles D Ericsson, MD

  University of Texas Medical School at Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ◦Professor and Dr. and Mrs. Carl V. Vartian Professor in Infectious Diseases

Study Record Dates

• First Submitted: April 3, 2009
• First Posted: April 6, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 10, 2015

Record last verified: 2015-06

Locations

ME (1)