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 Clinic Visit), and 2 safety follow-up phone calls; Once during Day 6 to 8, and on Day 30 (End of Study). Participants may complete both Screening and Day 1 on the same day. At the Screening visit, participants will provide a stool sample for PCR testing to identify the bacterial pathogen isolated. During the 5-day study period, the participant or their caregiver will complete a diary to record the dose, the time of dosing, time and consistency of stools, and incidence of symptoms as defined above. In addition, the participant or the caregiver will record any AEs in the eDiary from Day 4 to Day 30 with Day 1 to Day 3 assessed during study visits. Participants in the Xifaxan® 200 mg plus ORT arm will undergo two 6 to 8-hour pharmacokinetic sampling periods, the first following the first dose on Day 1 and the second following the first dose on Day 3. During these sampling periods, 3 blood samples (approximately 4 mL each) will be collected for analysis of rifaximin and 25- desacetyl rifaximin plasma concentrations at the following times: pre-dose, 1 hour (+/- 10 minutes) and no less than 6 but no more than 8 hours following the first dose of the day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
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.
Alliance Research Institute
Lynwood, California, United States
RECRUITINGDirect Helpers
Hialeah, Florida, United States
RECRUITINGSouthCoast Research Center
Miami, Florida, United States
RECRUITINGOceane7 Medical & Research Center, Inc
Miami, Florida, United States
RECRUITINGRophe Adult & Pediatric Medicine
Union City, Georgia, United States
RECRUITINGInnovative Clinical Research Center
Island Lake, Illinois, United States
RECRUITINGCyn3rgy Research Corporation
Gresham, Oregon, United States
RECRUITINGLittle Stars Pediatrics / Tattva Trials
Prosper, Texas, United States
RECRUITINGLinQ Research
Rosharon, Texas, United States
RECRUITINGTekton Research
Richmond, Virginia, United States
RECRUITINGPeak Plasma Concentration (Cmax) of Rifaximin
Cmax levels following rifaximin 200 mg + ORT
Time frame: Days 1 and 3
Time to Maximum Plasma Concentration (Tmax) of Rifaximin
Tmax for rifaximin following rifaximin 200 mg + ORT
Time frame: Days 1 and 3
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) for Rifaximin
Area under the concentration-time curve to last measurable concentration
Time frame: Days 1 and 3
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUC0-τ) for Rifaximin
Area under the concentration-time curve over the dosing interval
Time frame: Days 1 and 3
Proportion of participants with Clinical Cure
Proportion of participants achieving clinical cure, defined as either: 1. No unformed stools within a 48-hour period with no fever (with or without other clinical symptoms such as abdominal cramps or pain, excess gas/flatulence, nausea, vomiting, urgency, tenesmus); or 2. No watery stools and no more than two soft stools within a 24-hour period with no fever and no other clinical symptoms except for mild excess gas/flatulence.
Time frame: Up to Day 5 (End of Treatment)
Time to Last Unformed Stool (TLUS)
Time in hours from the first dose of study treatment to the last unformed stool, after which clinical cure is declared, based on subject/caregiver diary entries.
Time frame: Up to Day 5 (End of Treatment)
Incidence of Treatment-Emergent Adverse Events (AEs)
Number and percentage of participants with AEs and SAEs
Time frame: Day 1-30
Change From Baseline in Clinical Laboratory Parameters
Changes in hematology, chemistry, and urinalysis values
Time frame: Day 1-30
Change From Baseline in Vital Signs
Change in temperature, blood pressure, and pulse
Time frame: Day 1-30
Maryanne Santilli
CONTACT
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