Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera

NCT07795060 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: PISC-OND-CHOL-2026-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Pediatric cholera; Ondansetron; Oral rehydration solution; Vomiting; Dehydration; Intravenous fluids

Outcome Measures

Primary Outcomes (1)

• Oral Rehydration Failure

  Proportion of participants requiring clinically necessary, unplanned intravenous fluids because of failure of oral rehydration. The endpoint will be determined using prespecified criteria including persistent vomiting despite supervised ORS, failure to meet minimum weight-based ORS intake targets, and persistent or worsening signs of dehydration.

  Within 6 hours after enrollment

Secondary Outcomes (6)

• Vomiting Episodes

  At 4, 6, and 24 hours after enrollment

• Cumulative Oral Rehydration Solution Intake

  During hospitalization, approximately 24-48 hours after enrollment or until discharge

• Total Intravenous Fluid Volume

  During hospitalization, approximately 24-48 hours after enrollment or until discharge

• Time to Clinical Rehydration

  Up to 48 hours after enrollment

• Length of Hospital Stay

  Up to 48 hours after enrollment

Study Arms (2)

Standard Cholera Care

ACTIVE COMPARATOR

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

Other: Standard Cholera Care

Standard Care Plus Ondansetron

EXPERIMENTAL

Participants receive standard cholera care plus a single oral dose of ondansetron 0.15 mg/kg, up to a maximum dose of 8 mg.

Drug: Ondansetron; Other: Standard Cholera Care

Interventions

Ondansetron DRUG

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 Care Plus Ondansetron

Standard Cholera Care OTHER

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

Standard Care Plus Ondansetron; Standard Cholera Care

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Severe dehydration or shock requiring immediate intravenous rehydration
• Known allergy or contraindication to ondansetron
• Congenital long QT syndrome or known arrhythmia
• Concurrent use of QT-prolonging medications
• Inability to tolerate oral medication
• Lack of parent/guardian informed consent or required child assent

Sponsors & Collaborators

• Public Interest Science Center: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

University Hospital of Brazzaville (UHB) - Cholera Treatment Unit

Brazzaville, Republic of the Congo

Location

MeSH Terms

Conditions

Cholera; Osteoarthritis; Vomiting; Dehydration

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Armel Landry Batchi-Bouyou, MD, PhD, MPH

  Public Interest Science Center

  PRINCIPAL INVESTIGATOR

• Jason B, MD, MPH

  Massachusetts General Hospital

  STUDY CHAIR

Central Study Contacts

Armel Landry Batchi-Bouyou, MD, PhD, MPH

CONTACT

+242 061065810; armel.batchi@pi-sc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The trial is open-label for participants and treating clinicians. The primary outcome is adjudicated by a clinician not involved in bedside care who is masked to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 31, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

RE (1)