Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-24 @ 10:12 PM
NCT ID:
NCT03851835
Eligibility Criteria:
Inclusion Criteria:
* Willingness to comply with all study procedures and availability for the duration of the study.
* Diagnosis of acute intestinal infectious process (as defined by the protocol) confirmed. by the treating physician.
* Age 6 months to 17.99 years.
* Presence of ≥ 3 episodes of vomiting in the preceding 24-hour period.
* Duration of vomiting and/or diarrheal symptoms \< 72 hours.
* A minimum of 1 episode of vomiting within 6 hours of the screening process performed by the research team.
* A minimum of 1 dose of ondansetron (oral or intravenous) provided during the current emergency department visit.
Exclusion Criteria:
* Bilious or bloody vomit during current illness.
* Known hypersensitivity to ondansetron or any serotonin receptor antagonist (e.g. palonosetron, dolasetron, granisetron).
* Known allergic reaction to components of ondansetron (citric acid, sodium benzoate, sodium citrate dihydrate, and strawberry flavor, sorbitol) or the placebo medication (methylparaben, glycerin, citric acid, potassium sorbate, sorbitol, strawberry flavor).
* History or family history (first degree relative) of prolonged QT syndrome.
* Presence of complex congenital heart disease.
* History or family history (first degree relative) of cardiac arrhythmia.
* Concomitant use (within the past 48 hours) of any of the following: QTc prolonging medications, medications known to cause torsades de pointes, medications that cause electrolyte abnormalities, serotonergic or neuroleptic medications, or any 5-HT3 receptor antagonist excluding ondansetron.
* Unable to complete follow-up.
* Previously enrolled in this study.
* History or family history of G6PD deficiency.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
17 Years
Study:
NCT03851835
Study Brief:
Protocol Section:
NCT03851835