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

Launched by POLYSAN SCIENTIFIC & TECHNOLOGICAL PHARMACEUTICAL COMPANY · Jul 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well and how safely a medicine called Reamberin® works to treat viral infections of the intestines in young children aged 1 to 6 years old. These infections can cause symptoms like nausea, vomiting, fever, headache, and muscle pain. The trial aims to see if giving Reamberin® through an IV (a drip) along with fluids helps improve these symptoms and supports recovery in everyday medical care.

Children who might join this study need to be between 1 and 6 years old and have a confirmed viral intestinal infection, with symptoms that require treatment through IV fluids. A doctor will decide if Reamberin® is appropriate for the child, and parents must agree to have their child participate. During the trial, children will receive Reamberin® along with standard fluids like saline or glucose solutions. The trial is currently looking for participants and excludes children who are allergic to the medicine, need surgery, are already taking certain other medications, or have other health issues that might interfere with the study. Parents can expect their child to be closely monitored while receiving treatment to ensure it is safe and effective.

Gender

ALL

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