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

Polysan

Status: Enrolling

Conditions: Viral Enteric Infection

Treatments: Drug: Reamberin® solution for infusion, 1.5 %

Study type: Observational

Funder types: Industry

Identifiers

NCT07066540

REAMBERIN-05-2022

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Treatment group

Description:

Reamberin® in daily dose 10 mL/kg + normal saline (NaCl)/5 % or 10 % solution of glucose

Treatment:

Drug: Reamberin® solution for infusion, 1.5 %

Control group

Description:

Normal saline NaCl/Ringer's solution/5 % or 10 % solution of glucose