Cholera (Disorder)Phase 2NCT07795060
Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera
A Phase 2 study testing Ondansetron and Standard Cholera Care in people with Cholera (Disorder), run by Public Interest Science Center at 1 site in Republic of the Congo.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Cholera (Disorder)
- What is being tested?
- Ondansetron and Standard Cholera Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRepublic of the Congo
- Study dates
- 20 Oct 2026to 15 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Republic of the Congo1 site
University Hospital of Brazzaville (UHB) - Cholera Treatment Unit
Brazzaville
Armel Landry Batchi-Bouyou, MD, PhD, MPH, +242 061065810, armel.batchi@pi-sc.org
Armel Landry Batchi-Bouyou, MD, PhD, MPH
About this study
Official title: Oral Ondansetron to Prevent ORS Failure in Children With Cholera: A Phase IIa Trial
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.
Read the detailed description
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.
- Conditions
- Cholera (Disorder)
- Being tested
- Ondansetron, Standard Cholera Care
- Keywords
- Pediatric cholera, Ondansetron, Oral rehydration solution, Vomiting, Dehydration, Intravenous fluids
- Medical subject headings
- Cholera, Osteoarthritis, Vomiting, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
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 CareOther
Standard cholera management including oral rehydration solution (ORS), zinc supplementation, antibiotics when indicated, and supportive care according to WHO/GTFCC guidance.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ondansetron; Other: Standard Cholera Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 6 hours after enrollment
Secondary outcomes (6)
Vomiting Episodes
Number of vomiting episodes recorded for each participant after enrollment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 48 hours after enrollment
Length of Hospital Stay
Duration of hospitalization from enrollment until discharge.
Measured: 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.
Measured: From enrollment through Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start20 Oct 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholera (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Public Interest Science Center
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Sponsor
- Investigators
- Armel Landry Batchi-Bouyou, MD, PhD, MPH, Principal investigator, Public Interest Science CenterJason B, MD, MPH, Study chair, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795060
- Sponsor's protocol ID
- PISC-OND-CHOL-2026-01
- Status last verified
- Oct 2026
- First submitted
- 24 Aug 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned for public sharing. Study findings will be disseminated through aggregate analyses, scientific publications, and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Ondansetron to Prevent ORS Failure in Children With Cholera: A Phase IIa Trial
- ClinicalTrials.gov ID
- NCT07795060
- Acronym / sponsor ID
- PISC-OND-CHOL-2026-01
- Conditions
- Cholera (Disorder)
- Keywords
- Pediatric cholera, Ondansetron, Oral rehydration solution, Vomiting, Dehydration, Intravenous fluids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Public Interest Science CenterUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Cholera Care | Active comparator | Other: Standard Cholera CareParticipants receive 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 | Experimental | Drug: Ondansetron, Other: Standard Cholera CareParticipants receive standard cholera care plus a single oral dose of ondansetron 0.15 mg/kg, up to a maximum dose of 8 mg. |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OndansetronA 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. | Drug | Standard Care Plus Ondansetron |
| Standard Cholera CareStandard cholera management including oral rehydration solution (ORS), zinc supplementation, antibiotics when indicated, and supportive care according to WHO/GTFCC guidance. | Other | Standard Care Plus Ondansetron, Standard Cholera Care |
Primary outcome
Oral Rehydration Failure
Time frame: Within 6 hours after enrollment
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.
6 secondary outcomes
Vomiting Episodes
Time frame: At 4, 6, and 24 hours after enrollment
Cumulative Oral Rehydration Solution Intake
Time frame: During hospitalization, approximately 24-48 hours after enrollment or until discharge
Total Intravenous Fluid Volume
Time frame: During hospitalization, approximately 24-48 hours after enrollment or until discharge
Time to Clinical Rehydration
Time frame: Up to 48 hours after enrollment
Length of Hospital Stay
Time frame: Up to 48 hours after enrollment
Adverse Events
Time frame: From enrollment through Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned for public sharing. Study findings will be disseminated through aggregate analyses, scientific publications, and presentations.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Armel Landry Batchi-Bouyou, MD, PhD, MPH principal investigator
Public Interest Science Center
Jason B, MD, MPH study chair
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ondansetron and Standard Cholera Care in people with Cholera (Disorder), run by Public Interest Science Center at 1 site in Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Armel Landry Batchi-Bouyou, MD, PhD, MPH (+242 061065810, armel.batchi@pi-sc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Rehydration Failure (time frame: Within 6 hours after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.