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Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera

NCT07795060 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-08-31

No results posted yet for this study

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.

Conditions

  • Cholera (Disorder)

Interventions

DRUG

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.

OTHER

Standard Cholera Care

Standard cholera management including oral rehydration solution (ORS), zinc supplementation, antibiotics when indicated, and supportive care according to WHO/GTFCC guidance.

Sponsors & Collaborators

  • Thrasher Research Fund

    collaborator OTHER

  • Public Interest Science Center

    lead OTHER

Principal Investigators

  • Armel Landry Batchi-Bouyou, MD, PhD, MPH · Public Interest Science Center

  • Jason B, MD, MPH · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-03-01
Primary Completion
2027-12-01
Completion
2028-01-01

Countries

  • Republic of the Congo

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07795060 on ClinicalTrials.gov