Reamberin infusion for viral intestinal infection in children aged 1–6
Official title: 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
Run by POLYSAN Scientific & Technological Pharmaceutical Company · NCT07066540 · Data updated 2026-11-12
This program will test whether Reamberin infused with IV fluids helps children aged 1–6 who have viral enteric infection and need parenteral rehydration.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Year to 6 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | POLYSAN Scientific & Technological Pharmaceutical Company Industry-sponsored |
| Locations | 8 sites (Chelyabinsk and 7 other locations) |
| Status | Recruiting |
| Started | August 1, 2024 |
| Main results expected | June 2026 |
| Study ends | December 2026 |
| Registry record updated | July 15, 2025 |
| Trial ID | NCT07066540 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 1–6 years with a confirmed diagnosis of viral enteric infection who show signs of endogenous intoxication and have a clinical indication for parenteral rehydration, with a parent or guardian able to give informed consent.
✕Probably not a fit
Children outside the 1–6 age range, those with non-viral or severe bacterial enteritis, those not requiring IV fluids, or those with contraindications to Reamberin are unlikely to benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational program of Reamberin® solution for infusion (1.5%) given at a physician-prescribed dose of 10 mL/kg alongside standard IV fluids in routine clinical practice. Children aged 1–6 with a diagnosis of viral enteric infection (ICD-10 A08) and signs of systemic intoxication who require parenteral rehydration are enrolled after parental consent. The program records clinical outcomes such as symptom duration, need for additional interventions or hospitalization, and adverse events to describe safety and real-world effectiveness. Treatment decisions are made by the treating physician rather than randomized assignment.
Why it matters
Potential benefit: If successful, Reamberin use could shorten symptom duration and support recovery by improving rehydration and reducing toxin-related symptoms.
How similar studies have gone: Reamberin has prior clinical use and some small observational reports from regional practice suggesting symptomatic benefit for detoxification and fluid management, but high-quality randomized evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Children of both sexes at the age of 1 to 6 years old inclusive; 2. Diagnosis "Viral and other specified intestinal infections" (code according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision(ICD-10): A08), 3. Clinical signs of endogenous intoxication (nausea, vomiting, hyperthermia, headache, muscle pain, asthenia, adynamia, etc.); 4. Indication for parenteral rehydratation (infusion therapy); 5. Decision of a physician on prescribing drug product Reamberin® solution for infusion, 1.5 % (Scientific Technological Pharmaceutical Firm "POLYSAN") in the daily dose of 10 mL/kg and normal saline NaCl/5 % or 10 % solution of glucose or normal saline NaCl/Ringer's solution/5 % or 10 % solution of glucose; 6. To confirm the diagnosis by laboratory tests, biological material was taken; 7. Informed Consent Form on Participation in the Observational Program signed and dated by a parent/legal representative of the patient. Exclusion Criteria: 1. Individual intolerance or known hypersensitivity to sodium meglumine, sodium succinate, and/or normal saline (NaCl), solution of glucose, Ringer's solution or excipients of drug product Reamberin® based on data of medical history; 2. Contraindications to prescription of drug product Reamberin®; 3. Necessity in surgical interventions during the observational program; 4. Patients previously enrolled in this trial but discontinued participation due to any any reason; 5. Administration of antibiotics or succinate-containing drug products (Cytoflavin, Mexidol, etc.) and solutions containing malate; 6. Other conditions that, according to the Investigator, prevent enrollment of a patient into the observational trial or can result in premature discontinuation of the observational trial by the patient
Where it's running
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South Ural State Medical University
Chelyabinsk, Russia Recruiting -
Khimki Clinical Hospital
Khimki, Russia Recruiting -
Kuban State Medical University
Krasnodar, Russia Recruiting -
Infectious Diseases Clinical Hospital No. 1
Moscow, Russia Recruiting -
Z.A. Bashlyaeva Children's City Clinical Hospital
Moscow, Russia Recruiting -
Penza Regional Clinical Center for Specialized Types of Medical Care
Penza, Russia Recruiting
Show 2 more locations
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Children's Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency
Saint Petersburg, Russia Recruiting -
Samarkand State Medical University
Samarkand, Uzbekistan Recruiting
Study contacts
- Study coordinator: Alexey Kovalenko, Doc Biol Sci
- Email: science@polysan.ru
- Phone: +78127108225 Ext. 212
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.