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

ConditionsDiarrheaGastroenteritisBacterial Infection
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

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

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 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

1

Peak Plasma Concentration (Cmax) of Rifaximin

Cmax levels following rifaximin 200 mg + ORT

Time frame
Days 1 and 3
2

Time to Maximum Plasma Concentration (Tmax) of Rifaximin

Tmax for rifaximin following rifaximin 200 mg + ORT

Time frame
Days 1 and 3
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
4

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

1

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)
2

Incidence of Treatment-Emergent Adverse Events (AEs)

Number and percentage of participants with AEs and SAEs

Time frame
Day 1-30
3

Change From Baseline in Clinical Laboratory Parameters

Changes in hematology, chemistry, and urinalysis values

Time frame
Day 1-30
4

Change From Baseline in Vital Signs

Change in temperature, blood pressure, and pulse

Time frame
Day 1-30

Other outcomes

1

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
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