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

The University of Texas System (UT) logo

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Withdrawn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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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