{"id":"nct:NCT07795060","kind":"trial","title":"Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera","authors":["Public Interest Science Center"],"author_count":1,"year":2026,"published":"2026-08-31","venue":"ClinicalTrials.gov","cited_by":null,"doi":null,"arxiv_id":null,"nct_id":"NCT07795060","source_url":"https://clinicaltrials.gov/study/NCT07795060","archive_url":"https://space-kitty.com/papers/nct:NCT07795060","updated":"2026-10-19","pmid":null,"pmcid":null,"openalex_id":null,"pdf_url":null,"abstract":"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.","abstract_license":"ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters","license":"ClinicalTrials.gov terms (attribution, processing date, modifications noted)","is_open_access":true,"retracted":false,"peer_reviewed":null,"categories":["Cholera (Disorder)"],"details":{"acronym":null,"status":"NOT_YET_RECRUITING","phase":"PHASE2","study_type":"INTERVENTIONAL","enrollment":120,"sponsor":"Public Interest Science Center","conditions":["Cholera (Disorder)"],"interventions":["DRUG: Ondansetron","OTHER: Standard Cholera Care"],"start_date":"2026-10-20","start_date_type":"ESTIMATED","primary_completion_date":"2027-08-31","has_results":false,"data_source":"ClinicalTrials.gov","data_processed":"2026-10-29T09:00:05","modifications":"selected fields only; whitespace normalized; brief summary truncated to 2,000 characters"},"provenance":"clinicaltrials","attribution":"Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.","topics":[{"slug":"infectious-disease-amr","name":"Infectious Disease, Vaccines & Antimicrobial Resistance","domain_slug":"medicine"}],"cited_in_dossiers":[]}