Project Details

Oral Ondansetron to Prevent ORS Failure in Children with Cholera: A Phase IIa Trial

Armel Landry Batchi-Bouyou, MD, PhD, MPH

Summary

BACKGROUND: Cholera can cause rapid and life-threatening fluid loss in children. Oral rehydration solution (ORS) is the cornerstone of treatment, but repeated vomiting can prevent children from drinking enough ORS and may lead to intravenous (IV) fluid treatment. GAP: Ondansetron is an oral anti-vomiting medicine that is widely used in children with acute gastroenteritis, but it has not been adequately evaluated for children with cholera. Evidence is needed to determine whether a single dose can improve early ORS success and reduce the need for IV fluids. HYPOTHESIS: We hypothesize that adding a single oral dose of ondansetron to standard cholera care will reduce ORS failure within the first six hours of treatment without increasing adverse events. METHODS: This Phase IIa open-label randomized controlled trial will enroll approximately 120 children and adolescents aged 6 months to 17 years with suspected or confirmed cholera, active vomiting, and no or some dehydration at the University Hospital of Brazzaville Cholera Treatment Unit in the Republic of the Congo. Participants will be randomized 1:1 to standard cholera care alone or standard care plus a single weight-based oral dose of ondansetron. The primary outcome is clinically necessary, unplanned IV fluid use within six hours. RESULTS: Pending. IMPACT: If effective and safe, ondansetron could help more children complete oral rehydration successfully, reduce urgent IV cannulation and IV fluid use, and support simpler care during cholera outbreaks. Because ondansetron is inexpensive, oral, and widely available, positive findings could be rapidly evaluated for inclusion in cholera treatment protocols.