[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"viral-enteric-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:viral-enteric-infection":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100598057","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-100598057",false,"NCT07066540","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","Inclusion Criteria:\n\n1. Children of both sexes at the age of 1 to 6 years old inclusive;\n2. 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),\n3. Clinical signs of endogenous intoxication (nausea, vomiting, hyperthermia, headache, muscle pain, asthenia, adynamia, etc.);\n4. Indication for parenteral rehydratation (infusion therapy);\n5. 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\u002Fkg and normal saline NaCl\u002F5 % or 10 % solution of glucose or normal saline NaCl\u002FRinger's solution\u002F5 % or 10 % solution of glucose;\n6. To confirm the diagnosis by laboratory tests, biological material was taken;\n7. Informed Consent Form on Participation in the Observational Program signed and dated by a parent\u002Flegal representative of the patient.\n\nExclusion Criteria:\n\n1. Individual intolerance or known hypersensitivity to sodium meglumine, sodium succinate, and\u002For normal saline (NaCl), solution of glucose, Ringer's solution or excipients of drug product Reamberin® based on data of medical history;\n2. Contraindications to prescription of drug product Reamberin®;\n3. Necessity in surgical interventions during the observational program;\n4. Patients previously enrolled in this trial but discontinued participation due to any any reason;\n5. Administration of antibiotics or succinate-containing drug products (Cytoflavin, Mexidol, etc.) and solutions containing malate;\n6. 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","ALL","1 Year","6 Years",{"count":20,"type":21},300,"ESTIMATED","OBSERVATIONAL","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.",[25],"Viral Enteric Infection",[27,28],"viral enteric infection","reamberin","RECRUITING","2025-07-12",{"date":32,"type":33},"2025-07-15","ACTUAL",{"date":35,"type":33},"2024-08-01",{"date":37,"type":21},"2026-12",{"name":39,"class":40},"POLYSAN Scientific & Technological Pharmaceutical Company","INDUSTRY",8]