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A common anti-vomiting drug may keep cholera patients off IV drips

NCT ID NCT07795060

Disease control Sponsor: Public Interest Science Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether a single oral dose of ondansetron, a drug that curbs vomiting, can help children with cholera keep down oral rehydration solution (ORS). About 120 children aged 6 months to 17 years with suspected or confirmed cholera and active vomiting will receive either standard cholera care alone or standard care plus ondansetron. The main question is whether ondansetron reduces the need for unplanned IV fluids within 6 hours. The study also tracks vomiting episodes, ORS intake, and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ondansetron, a drug that reduces vomiting, given as a single oral dose alongside standard cholera care.
What this could lead to
If it works, this could offer a simple, low-cost way to keep more children with cholera hydrated by mouth, reducing the need for IV fluids and hospital stays.
What could go wrong
This is an early-phase trial with only 120 participants, so the results may not hold up in larger studies. Ondansetron can cause side effects like headache or constipation, and it may not reduce vomiting enough to change outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2027

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

cholera Dehydration osteoarthritis Vomiting

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cholera (disorder)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospital of Brazzaville (UHB) - Cholera Treatment Unit

    Brazzaville, Republic of the Congo