Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-12
SponsorBausch Health Americas, Inc.
About this trial
The goal of this clinical trial is to learn how rifaximin 200 mg is processed in the body (pharmacokinetics) in children 6 to 11 years old with acute diarrhea that may be caused by bacteria. It will also learn about the safety and effectiveness of rifaximin when given with oral rehydration therapy (ORT) compared with ORT alone. The main questions it aims to answer are:
How does rifaximin 200 mg move through and leave the body in children with acute diarrhea?
Is rifaximin safe for children in this age group?
Does rifaximin plus ORT help resolve diarrhea faster than ORT alone?
Researchers will compare rifaximin plus ORT to ORT alone to see if adding rifaximin improves outcomes.
Participants will:
Take one rifaximin 200 mg tablet + ORT three times a day for 3 days or receive ORT alone
Receive oral rehydration therapy according to the investigator's standard of care
Attend up to 4 clinic visits over 5 days and receive 4 follow-up phone calls
Provide blood samples on Day 1 and Day 3 for pharmacokinetic testing (rifaximin group only)
Provide stool samples to identify bacterial pathogens
Keep a diary of stool frequency and consistency to help determine when diarrhea resolves
Be monitored for side effects, vital signs, and laboratory changes
Eligibility criteria
Qualifiers
Parent/legally authorized representative and participant, as applicable, have provided written informed consent/assent, are able to understand, and agree to comply with, all study procedures and requirements.
Participant is between 6 to 11 years of age (inclusive)
Participant weighs at least 15 kg (33 lbs) at Screening
Participant is able to swallow pills
Disqualifiers
Participant has a history of chronic diarrhea (defined as loose or watery stools persisting for at last 4 consecutive weeks) within 12 months prior to onset of current acute illness.
Participant is unable to eat or drink.
Participant has clinical features suggestive of invasive or severe bacterial diarrhea requiring alternative therapy (e.g., frank blood in stool, mucoid diarrhea with systemic symptoms such as high fever, severe abdominal cramping or tenderness, or signs of sepsis).
Participant has taken >2 doses of anti-diarrheal therapies in the 24 hours prior to randomization.
Trial design
Treatments tested in this trial
- Rifaximin 200 mg Tablet
- Oral Rehydration Therapy (ORT)
Treatment groups
54 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov