Rosharon

Researchers are evaluating how rifaximin 200 mg is processed in the body and its safety and effectiveness in children aged 6 to 11 years with acute diarrhea that may be caused by bacterial infections such as E. coli, Shigella, Salmonella, or Campylobacter. This randomized, open-label Phase 4 trial compares rifaximin plus oral rehydration therapy (ORT) with ORT alone to see if adding rifaximin helps resolve diarrhea faster and to assess its safety in this age group. Participants are randomly assigned to receive either rifaximin 200 mg tablets taken orally three times a day for 3 days along with ORT or ORT alone according to the investigator's standard care. Blood samples for pharmacokinetic analysis are collected from those taking rifaximin on Day 1 and Day 3 at pre-dose, 1 hour post-dose, and 8 hours post-dose. Stool samples are collected to identify bacterial pathogens, and participants or caregivers keep a diary to record stool frequency, consistency, and symptoms. Throughout the 5-day study period, participants attend up to 4 clinic visits and receive follow-up phone calls on Days 6, 7, 8, and 30 to monitor safety and treatment effects. Safety assessments include monitoring adverse events, vital signs, and laboratory tests. The main outcomes measured include rifaximin blood levels, time to reach maximum concentration, and the proportion of participants with clinical cure by Day 5. Compliance with medication and ORT is also tracked.