Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera
Key facts
- Where
- Brazzaville, Congo - BrazzavilleSee the site
- Phase
- Phase 2
Where in Congo - Brazzaville
- University Hospital of Brazzaville (UHB) - Cholera Treatment UnitBrazzaville, Congo - BrazzavilleContact: Armel Landry Batchi-Bouyou, MD, PhD, MPHNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Public Interest Science Center
- Trial code
- NCT07795060
- Record updated
- 19 October 2026
- Original description
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.Read full original descriptionShow less
Oral Ondansetron to Prevent ORS Failure in Children With Cholera: A Phase IIa Trial
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.
Inclusion: Age 6 months to 17 years; Suspected or confirmed cholera; Active vomiting, defined as at least 1 episode within the preceding 4 hours; No dehydration or some dehydration according to WHO/GTFCC criteria; Parent/guardian able to provide informed consent; Assent from children aged 7 years or older, when applicable.
Exclusion: Inability to tolerate oral medication; Known allergy or contraindication to ondansetron; Congenital long QT syndrome or known arrhythmia; Concurrent use of QT-prolonging medications; Severe dehydration or shock requiring immediate intravenous rehydration; Lack of parent/guardian informed consent or required child assent.