Diarrhea Clinical Trial
— DOSE-AGEOfficial title:
Multi-dose Oral Ondansetron For Pediatric Gastroenteritis: A Pragmatic Randomized Controlled Trial
A phase III, double-blind, parallel-design, randomized, placebo controlled trial to compare multi-dose oral Ondansetron with placebo as treatment for vomiting secondary to acute gastroenteritis (AGE), after Emergency Department discharge.
Status | Recruiting |
Enrollment | 1030 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 17 Years |
Eligibility | Inclusion Criteria: - Diagnosis of acute intestinal infectious process (as defined by the protocol) confirmed. by the treating MD. - 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. - History or family history of G6PD deficiency - Unable to complete follow-up. - Previously enrolled in this study. |
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Children's Hospital | Calgary | Alberta |
Canada | Stollery Children's Hospital | Edmonton | Alberta |
Canada | Children's Hospital London Health Sciences Centre | London | Ontario |
Canada | Centre Hospitalier Universitaire Sainte Justine | Montreal | Quebec |
Canada | Children's Hospital of Eastern Ontario (CHEO) | Ottawa | Ontario |
Canada | Children's Hospital of Winnipeg | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Alberta Children's Hospital Research Institute, Canadian Institutes of Health Research (CIHR), Children's Hospital Research Institute of Manitoba, The Hospital for Sick Children, Université de Montréal, University of Alberta, University of Manitoba, University of Ottawa, Western University, Canada, Women and Children's Health Research Institute (WCHRI) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety Profile of Multiple Doses of Oral Ondansetron | To determine if the discharge of children with AGE associated vomiting who are administered ondansetron in the ED with additional doses to be taken at home is associated with adverse events (e.g. diarrhea, revisits) as compared with placebo. | Measured 24, 48, and 168 hours after baseline visit | |
Primary | Development of moderate to severe disease as defined by the Modified Vesikari Scale (MVS) Score of = 9 following ED evaluation - change in the MVS score between Hour 0 and Hour 168 of the study. | The Modified Vesikari Scale Score (MVS) is a composite measure which includes several variables representing the severity of disease - points are summed to provide an overall score:
Duration of diarrhea (hours): 0 (0 points), 1-96 (1 point), 97-120 (2 points), =121 (3 points) Maximum number of watery stools per 24 hour period: 0 (0 points), 1-3 (1 point), 4-5 (2 points), =6 (3 points) Duration of vomiting (hours): 0 (0 points), 1-24 (1 point), 25-48 (2 points), =49 (3 points) Maximum number of vomiting episodes per 24 hour period: none (0 points), 1 (1 point), 2-3 (2 points), =5 (3 points). Maximum recorded rectal temperature (degrees Celsius): <37.0 (0 points), 37.1-38.4 (1 point), 38.5-38.9 (2 points), =39.0 (3 points) Unscheduled health care visit: None (0 points), Primary Care (2 points), emergency department (3 points) Treatment: None (0 points), Rehydration with IV fluids (1 point), Hospitalization (2 points) |
Measured 24, 48, and 168 hours after baseline visit | |
Secondary | Vomiting Duration | Number of hours of vomiting following ED disposition. | Measured 24, 48, and 168 hours after baseline visit | |
Secondary | Vomiting Frequency | Number of episodes of vomiting following ED disposition. | Measured 24, 48, and 168 hours after baseline visit | |
Secondary | Vomiting Proportion | The proportion who experience vomiting following ED disposition. | Measured 24, 48, and 168 hours after baseline visit | |
Secondary | Proportion of participants who require an unscheduled health care visit | Unscheduled health care provider visits following Emergency Department disposition. Is there a difference in the proportion who require an unscheduled health care provider visit following ED disposition. | Measured 24, 48, and 168 hours after baseline visit | |
Secondary | Proportion of participants who require Intravenous (IV) Rehydration | Is there a difference in the proportion who require intravenous rehydration following ED disposition. | Measured 24, 48, and 168 hours after baseline visit | |
Secondary | Satisfaction with care: 5 point Likert Scale | Caregivers will be asked about their level of satisfaction with the therapy provided measured on the following 5 point Likert scale (choose one option):
1 - Very dissatisfied 2 - Dissatisfied 3 - Neither satisfied, nor dissatisfied 4 - Satisfied 5 - Very Satisfied |
168 hours after baseline |
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