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

Last updated: July 12, 2025
Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Reamberin® solution for infusion, 1.5 %

Clinical Study ID

NCT07066540
REAMBERIN-05-2022
  • Ages 1-6
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theInternational 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 forinfusion, 1.5 % (Scientific Technological Pharmaceutical Firm "POLYSAN") in thedaily dose of 10 mL/kg and normal saline NaCl/5 % or 10 % solution of glucose ornormal 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 datedby a parent/legal representative of the patient.

Exclusion

Exclusion Criteria:

  1. Individual intolerance or known hypersensitivity to sodium meglumine, sodiumsuccinate, and/or normal saline (NaCl), solution of glucose, Ringer's solution orexcipients 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 anyany 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 apatient into the observational trial or can result in premature discontinuation ofthe observational trial by the patient

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Reamberin® solution for infusion, 1.5 %
Phase:
Study Start date:
August 01, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • South Ural State Medical University

    Chelyabinsk,
    Russian Federation

    Active - Recruiting

  • Khimki Clinical Hospital

    Khimki,
    Russian Federation

    Active - Recruiting

  • Kuban State Medical University

    Krasnodar,
    Russian Federation

    Active - Recruiting

  • Infectious Diseases Clinical Hospital No. 1

    Moscow,
    Russian Federation

    Active - Recruiting

  • Z.A. Bashlyaeva Children's City Clinical Hospital

    Moscow,
    Russian Federation

    Active - Recruiting

  • Penza Regional Clinical Center for Specialized Types of Medical Care

    Penza,
    Russian Federation

    Active - Recruiting

  • Children's Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • Samarkand State Medical University

    Samarkand,
    Uzbekistan

    Active - Recruiting

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