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

The University of Texas System (UT)

Status and phase: Withdrawn; Phase 4

Conditions: Travelers' Diarrhea

Treatments: Drug: Rifaximin

Study type: Interventional

Funder types: Other

Identifiers

NCT00875875

Ericsson-001

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

1

Active Comparator group

Description:

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

Treatment:

Drug: Rifaximin

2

Active Comparator group

Description:

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

Treatment:

Drug: Rifaximin