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
Consent and assent are appropriately obtained prior to any study related activities, including discontinuation of any prohibited medications (subjects must sign an assent for the study and a parent or a legal guardian must sign the informed consent).
Subject is between 6 to 11 (and 11 months) years of age, inclusive, and weighs at least 15 kg (33 lbs) at Screening.
Females of childbearing (reproductive) potential must have a negative urine and serum pregnancy test at Screening and agree to use a highly effective method of contraception throughout their participation in the study. Acceptable methods of contraception are those alone or in combination, that result in a low failure rate (ie, less than 1% per year) when used consistently and correctly and include hormonal methods (oral, injected or implanted), intrauterine device or intrauterine system or double barrier methods (simultaneous use of a physical barrier method by the subject and male partner, including a male condom and an occlusive cap [diaphragm or cervical/vault cap] with spermicidal). Abstinence or partner(s) with a vasectomy may be considered an acceptable method of contraception at the discretion of the Investigator.
At least 3 unformed stools in the last 24 hours prior to Screening.
Disqualifiers
Subject has a history of chronic diarrhea.
Subject is unable to eat or drink.
Presence of fever >39°C (>102.2°F).
Presence of frank blood in stool.
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