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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

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

Recruiting
1-6 years
All
Phase N/A

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Overview

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.

Eligibility

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

Study details
    Viral Enteric Infection

NCT07066540

POLYSAN Scientific & Technological Pharmaceutical Company

16 October 2025

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