# Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera

Clinical trial · Public Interest Science Center

- Archive id: nct:NCT07795060
- Published: 2026-08-31
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07795060
- Source URL: https://clinicaltrials.gov/study/NCT07795060
- Provenance: clinicaltrials

## Abstract

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.

_Abstract reproduced under ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters._

## Trial details

- status: NOT_YET_RECRUITING
- phase: PHASE2
- study type: INTERVENTIONAL
- enrollment: 120
- sponsor: Public Interest Science Center
- conditions: Cholera (Disorder)
- interventions: DRUG: Ondansetron; OTHER: Standard Cholera Care
- start date: 2026-10-20
- start date type: ESTIMATED
- primary completion date: 2027-08-31
- has results: false
- data source: ClinicalTrials.gov
- data processed: 2026-10-29T09:00:05
- modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters

Topics: [Infectious Disease, Vaccines & Antimicrobial Resistance](https://space-kitty.com/topics/infectious-disease-amr)

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