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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Reamberin® solution for infusion, 1.5 %
  Reamberin® in daily dose 10 mL/kg

Первичные конечные точки

• Proportion of patients in groups who continued to receive infusion therapy 24 hours and 48 hours after the start of the treatment [Срок оценки: 24 hours, 48 hours]
• Average duration of infusion therapy in groups, expressed in days [Срок оценки: Day 10]
• Average durations of symptoms of damage of the gastrointestinal tract in groups [Срок оценки: Day 10]
• Average duration of symptoms of intoxication in groups [Срок оценки: Day 10]
• Share of patients in groups with moderate form and severe form 48 hours after the start of the treatment [Срок оценки: 48 hours]
• Average duration of stay of patients in an inpatient healthcare facility [Срок оценки: Day 10]

Вторичные конечные точки (10)

• Average volume of infusion therapy relative to body weight [Срок оценки: Day 10]
• Dynamics of intoxication symptoms after 24 hours and 48 hours [Срок оценки: 24 hours, 48 hours]
• Proportion of patients with electrolyte disturbances after 24 hours [Срок оценки: 24 hours]
• Proportion of patients with base deficit (BE) less than 2 mmol/L after 24 hours [Срок оценки: 24 hours]
• Dynamics of fever severity after 24 hours and 48 hours [Срок оценки: 24 hours, 48 hours]
• Average duration of fever [Срок оценки: Day 10]
• Average duration of stay in the ICU [Срок оценки: Day 10]
• Dynamics of symptoms of damage of the GI tract 24 hours and 48 hours [Срок оценки: 24 hours, 48 hours]
• Dynamics of severity of dehydratation according to the CDS clinical scale 24 hours and 48 hours after the start of infusion therapy [Срок оценки: 24 hours, 48 hours]
• Dynamics of changes of parameters of complete blood count and leukocytic index of intoxication 24 hours and 48 hours [Срок оценки: 24 hours, 48 hours]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Россия · 7 центров

• South Ural State Medical University — Chelyabinsk
• Khimki Clinical Hospital — Khimki
• Kuban State Medical University — Krasnodar
• Infectious Diseases Clinical Hospital No. 1 — Moscow
• Z.A. Bashlyaeva Children's City Clinical Hospital — Moscow
• Penza Regional Clinical Center for Specialized Types of Medical Care — Penza
• Children's Scientific and Clinical Center for Infectious Diseases of the Federal Medical a — Saint Petersburg

Узбекистан · 1 центр

• Samarkand State Medical University — Samarkand

Идентификаторы

NCT: NCT07066540 · REAMBERIN-05-2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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