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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- Proportion of patients in groups who continued to receive infusion therapy 24 hours and 48 hours after the start of the treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Treatment group
Reamberin® in daily dose 10 mL/kg + normal saline (NaCl)/5 % or 10 % solution of glucose
干预措施: Reamberin® solution for infusion, 1.5 % (Drug)
结局指标
主要结局
Proportion of patients in groups who continued to receive infusion therapy 24 hours and 48 hours after the start of the treatment
时间窗: 24 hours, 48 hours
Share of patients in groups who continued to receive infusion therapy 24 h (Visit 2) and 48 h (Visit 3) after the start of the treatment
Average duration of infusion therapy in groups, expressed in days
时间窗: Day 10
Average duration of infusion therapy in groups, expressed in days
Average durations of symptoms of damage of the gastrointestinal tract in groups
时间窗: Day 10
Average durations of symptoms of damage of the gastrointestinal tract (nausea, vomiting, diarrhea) in groups, expressed in days;
Average duration of symptoms of intoxication in groups
时间窗: Day 10
Average duration of symptoms of intoxication (asthenia, lethargy, hypodynamia) in groups, expressed in days
Share of patients in groups with moderate form and severe form 48 hours after the start of the treatment
时间窗: 48 hours
Share of patients in groups with moderate form (11-15 points according to the Vesikari scale) and severe form (16 and more points according to the Vesikari scale) 48 hours after the start of the treatment (Visit 3);
Average duration of stay of patients in an inpatient healthcare facility
时间窗: Day 10
Average duration of stay of patients in an inpatient healthcare facility in treatment groups, expressed in days
次要结局
- Average volume of infusion therapy relative to body weight(Day 10)
- Dynamics of intoxication symptoms after 24 hours and 48 hours(24 hours, 48 hours)
- Proportion of patients with electrolyte disturbances after 24 hours(24 hours)
- Proportion of patients with base deficit (BE) less than 2 mmol/L after 24 hours(24 hours)
- Dynamics of fever severity after 24 hours and 48 hours(24 hours, 48 hours)
- Average duration of fever(Day 10)
- Average duration of stay in the ICU(Day 10)
- Dynamics of symptoms of damage of the GI tract 24 hours and 48 hours(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(24 hours, 48 hours)
- Dynamics of changes of parameters of complete blood count and leukocytic index of intoxication 24 hours and 48 hours(24 hours, 48 hours)