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
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
POLYSAN Scientific & Technological Pharmaceutical Company
300 participants
Aug 1, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria7
- Children of both sexes at the age of 1 to 6 years old inclusive;
- 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),
- Clinical signs of endogenous intoxication (nausea, vomiting, hyperthermia, headache, muscle pain, asthenia, adynamia, etc.);
- Indication for parenteral rehydratation (infusion therapy);
- 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;
- To confirm the diagnosis by laboratory tests, biological material was taken;
- Informed Consent Form on Participation in the Observational Program signed and dated by a parent/legal representative of the patient.
Exclusion Criteria6
- 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;
- Contraindications to prescription of drug product Reamberin®;
- Necessity in surgical interventions during the observational program;
- Patients previously enrolled in this trial but discontinued participation due to any any reason;
- Administration of antibiotics or succinate-containing drug products (Cytoflavin, Mexidol, etc.) and solutions containing malate;
- 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
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Interventions
Reamberin® in daily dose 10 mL/kg
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT07066540