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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-6
SponsorPOLYSAN Scientific & Technological Pharmaceutical Company

About this trial

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 criteria

Qualifiers

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);

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Reamberin® solution for infusion, 1.5 %

Treatment groups

300 Participants
are divided into 2 treatment groups