NCT07066540

Trial of the Efficacy and Safety of Use of Drug Product Reamberin® for Pathogenetic Therapy of Viral Enteric Infection in Children Aged 1-6 Years Old

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company · Industry
• Sex: All
• Age: 1 Year – 6 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Viral Enteric Infection

Interventions

Type	Name	Description
DRUG	Reamberin® solution for infusion, 1.5 %	Reamberin® in daily dose 10 mL/kg

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2025-07-15
• Last updated: 2025-07-15

Locations

8 sites across 2 countries: Russia, Uzbekistan