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Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera
Sponsor: Public Interest Science Center
Summary
This Phase IIa randomized controlled trial will evaluate whether a single oral dose of ondansetron can reduce oral rehydration failure in children and adolescents with suspected or confirmed cholera and active vomiting. Approximately 120 participants aged 6 months to 17 years with no or some dehydration will be randomized 1:1 to receive standard cholera care alone or standard care plus oral ondansetron 0.15 mg/kg, up to a maximum dose of 8 mg. The primary outcome is oral rehydration failure within 6 hours, defined as initiation of clinically necessary, unplanned intravenous fluids. Secondary outcomes include vomiting frequency, oral rehydration solution intake, intravenous fluid volume, time to clinical rehydration, length of stay, and safety outcomes.
Official title: Oral Ondansetron to Prevent ORS Failure in Children With Cholera: A Phase IIa Trial
Key Details
Gender
All
Age Range
6 Months - 17 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2027-03-01
Completion Date
2028-01-01
Last Updated
2026-08-31
Healthy Volunteers
No
Conditions
Interventions
Ondansetron
A single oral dose of ondansetron 0.15 mg/kg, up to a maximum dose of 8 mg, administered at enrollment as an oral tablet or orally disintegrating tablet according to age and ability to swallow.
Standard Cholera Care
Standard cholera management including oral rehydration solution (ORS), zinc supplementation, antibiotics when indicated, and supportive care according to WHO/GTFCC guidance.
Locations (1)
University Hospital of Brazzaville (UHB) - Cholera Treatment Unit
Brazzaville, Republic of the Congo