A Phase 2 interventional study of Ondansetron and Standard Cholera Care in Cholera (Disorder), sponsored by Public Interest Science Center. Not yet recruiting at 1 site in Republic of the Congo. Open to participants aged 6 Months to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Public Interest Science Center · Phase 2, Interventional, and Treatment
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.
Cholera can cause rapid fluid loss and severe dehydration, particularly in children. Oral rehydration solution (ORS) is the cornerstone of treatment, but persistent vomiting can interfere with adequate ORS intake and lead to escalation to intravenous fluid therapy. Ondansetron is an antiemetic commonly used in children with acute gastroenteritis, but it has not been formally evaluated for preventing oral rehydration failure in children with cholera.
This open-label, randomized, controlled Phase IIa trial will enroll approximately 120 children and adolescents aged 6 months to 17 years at the University Hospital of Brazzaville Cholera Treatment Unit in the Republic of the Congo. Eligible participants will have suspected or confirmed cholera, active vomiting, and no or some dehydration. Participants with severe dehydration or shock will receive immediate guideline-based intravenous rehydration and will not be randomized.
Participants will be randomized 1:1 to standard cholera management alone or standard care plus a single oral dose of ondansetron at 0.15 mg/kg, with a maximum dose of 8 mg. The primary endpoint is oral rehydration failure within 6 hours of enrollment, defined as initiation of clinically necessary, unplanned intravenous fluids. Secondary outcomes include vomiting episodes, cumulative ORS intake, intravenous fluid volume, time to clinical rehydration, length of hospital stay, and adverse events. Participants will be observed during hospitalization and will undergo brief follow-up approximately 7 days after enrollment for delayed adverse events.
83 studies on the registry are indexed under Cholera; 16 are open to participants now.
This study's planned enrollment of 120 is below the median of 262 across 72 interventional studies indexed under Cholera.
Browse Cholera studies →This is the only study on the registry with Public Interest Science Center as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 cholera management including oral rehydration solution (ORS), zinc supplementation, antibiotics when indicated, and supportive care according to WHO/GTFCC guidance.
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.
Time frame: Within 6 hours after enrollment
Vomiting Episodes
Number of vomiting episodes recorded for each participant after enrollment.
Time frame: At 4, 6, and 24 hours after enrollment
Cumulative Oral Rehydration Solution Intake
Total volume of oral rehydration solution (ORS) consumed by each participant during the clinical observation period.
Time frame: During hospitalization, approximately 24-48 hours after enrollment or until discharge
Total Intravenous Fluid Volume
Total volume of intravenous fluids administered to each participant during the clinical observation period.
Time frame: During hospitalization, approximately 24-48 hours after enrollment or until discharge
Time to Clinical Rehydration
Time from enrollment to achievement of clinical rehydration based on standardized clinical assessment.
Time frame: Up to 48 hours after enrollment
Length of Hospital Stay
Duration of hospitalization from enrollment until discharge.
Time frame: Up to 48 hours after enrollment
Adverse Events
Adverse events will be actively monitored and tabulated by treatment group and severity using CTCAE v5.0. An ECG will be obtained if symptoms suggestive of arrhythmia occur.
Time frame: From enrollment through Day 7
Plan to share: No — Individual participant data are not planned for public sharing. Study findings will be disseminated through aggregate analyses, scientific publications, and presentations.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Aug 2027, 10 months later.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 19, 2026: start Mar 2027 → Oct 2026, primary completion Dec 2027 → Aug 2027 and completion Jan 2028 → Sep 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ondansetron