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
Observational Study
Viral Enteric Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
1 – 6
Sex
Any
Study type
Observational
Participants needed
300 (estimated)
Sponsor
POLYSAN Scientific & Technological Pharmaceutical Company · Industry
Who this trial is looking for
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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.
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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 sig…
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
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