Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera

Cholera can cause rapid fluid loss and severe dehydration, particularly in children. Oralrehydration solution (ORS) is the cornerstone of treatment, but persistent vomiting caninterfere with adequate ORS intake and lead to escalation to intravenous fluid therapy.Ondansetron is an antiemetic commonly used in children with acute gastroenteritis, but ithas not been formally evaluated for preventing oral rehydration failure in children withcholera.This open‐label, randomized, controlled Phase IIa trial will enroll approximately 120children and adolescents aged 6 months to 17 years at the University Hospital ofBrazzaville Cholera Treatment Unit in the Republic of the Congo. Eligible participantswill have suspected or confirmed cholera, active vomiting, and no or some dehydration.Participants with severe dehydration or shock will receive immediate guideline‐basedintravenous rehydration and will not be randomized.Participants will be randomized 1:1 to standard cholera management alone or standard careplus a single oral dose of ondansetron at 0.15 mg/kg, with a maximum dose of 8 mg. Theprimary endpoint is oral rehydration failure within 6 hours of enrollment, defined asinitiation of clinically necessary, unplanned intravenous fluids. Secondary outcomesinclude vomiting episodes, cumulative ORS intake, intravenous fluid volume, time toclinical rehydration, length of hospital stay, and adverse events. Participants will beobserved during hospitalization and will undergo brief follow‐up approximately 7 daysafter enrollment for delayed adverse events.