Reamberin infusion for viral intestinal infection in children aged 1–6

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

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
• Enrollment: 300 (estimated)
• Ages: 1 Year to 6 Years
• Sex: All
• Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company (industry)
• Locations: 8 sites (Chelyabinsk and 7 other locations)
• Trial ID: NCT07066540 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Chelyabinsk and 7 other locations

• 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)
• 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

Conditions: Viral Enteric Infection, viral enteric infection, reamberin