Actively Recruiting
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
Led by POLYSAN Scientific & Technological Pharmaceutical Company · Updated on 2025-07-15
300
Participants Needed
8
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children of both sexes aged 1 to 6 years old inclusive
- Diagnosis of viral and other specified intestinal infections (ICD-10 code: A08)
- Clinical signs of endogenous intoxication such as nausea, vomiting, fever, headache, muscle pain, weakness, or fatigue
- Indication for infusion therapy (parenteral rehydration)
- Physician's decision to prescribe Reamberin� solution for infusion, 1.5% at 10 mL/kg daily dose with appropriate fluid solutions
- Diagnosis confirmed by laboratory tests with biological material taken
- Signed informed consent form by a parent or legal representative
You will not qualify if you...
- Known intolerance or hypersensitivity to sodium meglumine, sodium succinate, normal saline, glucose solutions, Ringer's solution, or Reamberin� excipients
- Contraindications to prescribing Reamberin�
- Need for surgical intervention during the trial
- Previous enrollment in this trial with discontinued participation for any reason
- Use of antibiotics or succinate-containing drugs (such as Cytoflavin, Mexidol) or malate-containing solutions
- Any other condition that prevents enrollment or may cause early trial discontinuation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
South Ural State Medical University
Chelyabinsk, Russia
Actively Recruiting
2
Khimki Clinical Hospital
Khimki, Russia
Actively Recruiting
3
Kuban State Medical University
Krasnodar, Russia
Actively Recruiting
4
Infectious Diseases Clinical Hospital No. 1
Moscow, Russia
Actively Recruiting
5
Z.A. Bashlyaeva Children's City Clinical Hospital
Moscow, Russia
Actively Recruiting
6
Penza Regional Clinical Center for Specialized Types of Medical Care
Penza, Russia
Actively Recruiting
7
Children's Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency
Saint Petersburg, Russia
Actively Recruiting
8
Samarkand State Medical University
Samarkand, Uzbekistan
Actively Recruiting
Research Team
A
Alexey Kovalenko, Doc Biol Sci
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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