Bausch Health Americas, Inc.
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
This is a randomized, open-label study to assess the pharmacokinetics of Xifaxan® 200 mg in pediatric participants 6 to 11 years of age with acute diarrhea of suspected bacterial etiology, and safety and efficacy Xifaxan® 200 mg plus ORT compared to ORT alone. Participants will receive Xifaxan® 200mg (1 tablet) TID plus oral rehydration therapy (ORT) or ORT alone as per the Investigator's Standard of Care (SOC) for administering ORS for three days. Participants will complete 3 or 4 study visits during the study; Screening (Day -2 to Day 1), Day 1, Day 3 (End of Treatment), and Day 5 (Last Cl…
4.1 Inclusion Criteria A participant will be eligible for inclusion in this study if all of the following criteria are met: 1. 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. 2. Participant is between 6 to 11 years of age (inclusive) 3. Participant weighs at least 15 kg (33 lbs) at Screening 4. Participant is able to swallow pills 5. Participant has diarrhea of suspected bacterial etiology defined by: 1. At least 3 unformed stool…
Participants receive rifaximin 200 mg tablets orally three times daily (TID) for 3 days in combination with oral rehydration therapy (ORT). Blood samples for pharmacokinetic analysis are collected on Day 1 and Day 3 at pre-dose, 1 hour post-dose, and 6 to 8 hours post-dose.
Participants receive oral rehydration solution according to the investigator's standard of care. This is administered either alone (for the ORT-alone arm) or in combination with rifaximin (for the rifaximin + ORT arm). Participants or caregivers complete a daily diary documenting stool frequency, stool consistency, and related symptoms.