None listed
Conditions
Interventions
Dexecadotril Type of group
One takes immediately to the inclusion, followed by 3 daily doses, without exceeding 7 days.
Group name:Racecadotril Type of group
One takes immediately to the inclusion, followed by 3 daily doses, without exceeding 7 days.
Sponsors
BIOPROJET,
Eligibility
Inclusion criteria
Inclusion criteria: - male patient older than 1 month and younger than 3 years, - suffering from acute diarrhea, of presumed infectious origin, defined as a sudden increase in the number of stools characterized by the following 3 mandatory criteria: * at least 3 or more watery or loose stools within the last 24 hours, * Duration of diarrhea (from first diarrheal stool): at least 24 hours and not more than 72 hours until the moment of inclusion * the child requires hospitalization - written informed consent of the parents.
Exclusion criteria
Exclusion criteria: - previous episode of diarrhea within the last 2 weeks. - presence of blood in the stools. - the patient has received treatment with an antibiotic at therapeutic or acid doses acetylsalicylic, or some anti-diarrheic, within 72 hours before its inclusion. - Severe malnutrition defined as a weight index for height less than 70% of the average NCSH, - presence of any other disease or condition that requires antibiotic therapy at the time of its inclusion. - Severe dehydration requiring intravenous rehydration. - Known hypersensitivity to racecadotril. - concomitant disease that may interfere with the study. - patients participating in another study, or who have participated in another study the previous month, or have already participated in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The weight of stools in the first 48 hours. Measure:VALUATION OF THE SEVERITY OF THE DIARRHEA Timepoints:48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:• the discharge of stool from the first 24 hours. • the total discharge of stool until recovery. • the recovery percentage at the last visit. • the duration of diarrhea (period between the first intake of treatment [HO] and the last deposition not formed before recovery). • the total intake of the oral rehydration solution. • total volume of vomiting. • Subgroup analysis according to rotavirus status (positive or negative). Measure:VALUATION OF THE SEVERITY OF THE DIARRHEA Timepoints:24 hours | — |
Countries
Peru, United States
Outcome results
None listed