Phase
Condition
N/ATreatment
Reamberin® solution for infusion, 1.5 %
Clinical Study ID
Ages 1-6 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Children of both sexes at the age of 1 to 6 years old inclusive;
Diagnosis "Viral and other specified intestinal infections" (code according to theInternational 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 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;
To confirm the diagnosis by laboratory tests, biological material was taken;
Informed Consent Form on Participation in the Observational Program signed and datedby a parent/legal representative of the patient.
Exclusion
Exclusion Criteria:
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;
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 anyany 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 apatient into the observational trial or can result in premature discontinuation ofthe observational trial by the patient
Study Design
Connect with a study center
South Ural State Medical University
Chelyabinsk,
Russian FederationActive - Recruiting
Khimki Clinical Hospital
Khimki,
Russian FederationActive - Recruiting
Kuban State Medical University
Krasnodar,
Russian FederationActive - Recruiting
Infectious Diseases Clinical Hospital No. 1
Moscow,
Russian FederationActive - Recruiting
Z.A. Bashlyaeva Children's City Clinical Hospital
Moscow,
Russian FederationActive - Recruiting
Penza Regional Clinical Center for Specialized Types of Medical Care
Penza,
Russian FederationActive - Recruiting
Children's Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency
Saint Petersburg,
Russian FederationActive - Recruiting
Samarkand State Medical University
Samarkand,
UzbekistanActive - Recruiting
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