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Open Multicenter Prospective Observational Trial of the Efficacy and Safety of Use of Drug Product Reamberin® Solution for Infusion, 1.5 % (Scientific Technological Pharmaceutical Firm "POLYSAN") for Pathogenetic Therapy of Viral Enteric Infection in Children Aged 1-6 Years Old
To assess the efficacy and safety of use of drug product Reamberin® solution for infusion, 1.5 % (Scientific Technological Pharmaceutical Firm "POLYSAN") for pathogenetic therapy of viral enteric infection in children aged 1-6 years old in routine clinical practice. Trial population: children of both sexes at the age of 1-6 years old inclusive with viral enteric infection.
Details
| Lead sponsor | POLYSAN Scientific & Technological Pharmaceutical Company |
|---|---|
| Status | RECRUITING |
| Enrolment | 300 |
| Start date | 2024-08-01 |
| Completion | 2026-12 |
Conditions
- Viral Enteric Infection
Interventions
- Reamberin® solution for infusion, 1.5 %
Primary outcomes
- Proportion of patients in groups who continued to receive infusion therapy 24 hours and 48 hours after the start of the treatment — 24 hours, 48 hours
Share of patients in groups who continued to receive infusion therapy 24 h (Visit 2) and 48 h (Visit 3) after the start of the treatment - Average duration of infusion therapy in groups, expressed in days — Day 10
Average duration of infusion therapy in groups, expressed in days - Average durations of symptoms of damage of the gastrointestinal tract in groups — Day 10
Average durations of symptoms of damage of the gastrointestinal tract (nausea, vomiting, diarrhea) in groups, expressed in days; - Average duration of symptoms of intoxication in groups — Day 10
Average duration of symptoms of intoxication (asthenia, lethargy, hypodynamia) in groups, expressed in days - Share of patients in groups with moderate form and severe form 48 hours after the start of the treatment — 48 hours
Share of patients in groups with moderate form (11-15 points according to the Vesikari scale) and severe form (16 and more points according to the Vesikari scale) 48 hours after the start of the treatment (Visit 3); - Average duration of stay of patients in an inpatient healthcare facility — Day 10
Average duration of stay of patients in an inpatient healthcare facility in treatment groups, expressed in days
Countries
Russia, Uzbekistan