Study of Rifaximin 200 mg with Oral Rehydration Therapy in Children 6 to 11 Years With Bacterial Acute Diarrhea Assessing Safety, Effectiveness, and How the Drug is Processed in the Body

What this Trial Is About

This research aims to understand how rifaximin 200 mg is processed in the bodies of children aged 6 to 11 years with acute diarrhea suspected to be caused by bacteria. It also evaluates the safety of rifaximin in this age group and compares the effectiveness of rifaximin combined with oral rehydration therapy ORT versus ORT alone in resolving diarrhea. The trial focuses on children experiencing bacterial-related acute diarrhea symptoms like frequent unformed stools and fever. Participants are randomly assigned to one of two groups one group receives rifaximin 200 mg tablets three times daily for 3 days along with ORT, while the other group receives only ORT as per standard care. Blood samples are collected from those in the rifaximin group on Days 1 and 3 at specific times to study how the drug moves through the body. Stool samples are taken to identify the bacteria causing diarrhea. Participants or their caregivers keep daily diaries recording stool frequency, consistency, and related symptoms. During the 5-day study, participants attend up to four clinic visits and receive follow-up phone calls on Days 6, 7, 8, and 30 to monitor safety and collect diary information. Researchers assess side effects, vital signs, and lab tests to monitor safety. They measure rifaximin levels in blood samples and track how quickly diarrhea resolves. Compliance with treatment and ORT is monitored throughout, providing comprehensive data on pharmacokinetics, safety, and efficacy of rifaximin plus ORT in children with acute bacterial diarrhea.

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