Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea

ConditionsDiarrhea Gastroenteritis Bacterial Infection 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Rifaximin 200 mg Tablet
Drug
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.
Oral Rehydration Therapy (ORT)
Other intervention
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.

Treatment groups

54 Participants

are divided into 2 treatment groups

Group A: Rifaximin 200 mg + ORTExperimental treatment 2 interventions

Group B: ORT AloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

Peak 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

Secondary outcomes

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

Other outcomes

Detection of Bacterial Pathogens in stool samples

Identification of bacterial pathogen(s) isolated from stool samples of enrolled participants.

Time frame

Screening (Day -2 to Day 1)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bausch Health Americas, Inc.

Lead sponsor

Source ClinicalTrials.gov

Apply now