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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Reamberin® in daily dose 10 mL/kg + normal saline (NaCl)/5 % or 10 % solution of glucose |
| |
| Control group | Normal saline NaCl/Ringer's solution/5 % or 10 % solution of glucose |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reamberin® solution for infusion, 1.5 % | Drug | Reamberin® in daily dose 10 mL/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients in groups who continued to receive infusion therapy 24 hours and 48 hours after the start of the treatment | 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 | 24 hours, 48 hours |
| Average duration of infusion therapy in groups, expressed in days | Average duration of infusion therapy in groups, expressed in days | Day 10 |
| Average durations of symptoms of damage of the gastrointestinal tract in groups | Average durations of symptoms of damage of the gastrointestinal tract (nausea, vomiting, diarrhea) in groups, expressed in days; | Day 10 |
| Average duration of symptoms of intoxication in groups | Average duration of symptoms of intoxication (asthenia, lethargy, hypodynamia) in groups, expressed in days | Day 10 |
| Share of patients in groups with moderate form and severe form 48 hours after the start of the treatment | 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); | 48 hours |
| Average duration of stay of patients in an inpatient healthcare facility | Average duration of stay of patients in an inpatient healthcare facility in treatment groups, expressed in days | Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Average volume of infusion therapy relative to body weight | Average volume of infusion therapy relative to body weight, expressed in milliliters | Day 10 |
| Dynamics of intoxication symptoms after 24 hours and 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Children of both sexes at the age of 1-6 years old inclusive with viral enteric infection
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexey Kovalenko, Doc Biol Sci | Contact | +78127108225 Ext. 212 | science@polysan.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Ural State Medical University | Recruiting | Chelyabinsk | Russia | |||
| Khimki Clinical Hospital |
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Dynamics of intoxication symptoms (weakness, lethargy, hypodynamia), assessed by VAS (Visual analog scale) after 24 hours (Visit 2) and 48 hours (Visit 3) from the start of infusion therapy compared to Visit 1;
| 24 hours, 48 hours |
| Proportion of patients with electrolyte disturbances after 24 hours | Proportion of patients with electrolyte disturbances after 24 hours (Visit 2) from the start of infusion therapy compared to Visit 1 (among patients who underwent electrolyte level testing at Visits 1 and 2); | 24 hours |
| Proportion of patients with base deficit (BE) less than 2 mmol/L after 24 hours | Proportion of patients with base deficit (BE) less than 2 mmol/L after 24 hours from the start of infusion therapy (among patients who underwent this testing at Visits 1 and 2); | 24 hours |
| Dynamics of fever severity after 24 hours and 48 hours | Dynamics of fever severity after 24 hours (Visit 2) and 48 hours (Visit 3) from the start of infusion therapy compared to Visit 1, expressed in degrees Celsius; | 24 hours, 48 hours |
| Average duration of fever | Average duration of fever, expressed in days | Day 10 |
| Average duration of stay in the ICU | Average duration of stay in the ICU (intensive care unit), expressed in hours (among patients transferred into ICU) | Day 10 |
| Dynamics of symptoms of damage of the GI tract 24 hours and 48 hours | Dynamics of symptoms of damage of the GI (gastrointestinal) tract (nausea, vomiting, and diarrhea) 24 hours (Visit 2) and 48 hours (Visit 3) after the start of infusion therapy as compared to Visit 1; | 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 | Dynamics of severity of dehydratation according to the CDS (Clinical Dehydration Scale) clinical scale 24 hours (Visit 2) and 48 hours (Visit 3) after the start of infusion therapy as compared to Visit 1, expressed in points; | 24 hours, 48 hours |
| Dynamics of changes of parameters of complete blood count and leukocytic index of intoxication 24 hours and 48 hours | Dynamics of changes of parameters of complete blood count and leukocytic index of intoxication 24 hours (Visit 2) and 48 hours (Visit 3) after the start of treatment as compared to Visit 1 (among patients who underwent this analysis). | 24 hours, 48 hours |
| Recruiting |
| Khimki |
| Russia |
| Kuban State Medical University | Recruiting | Krasnodar | Russia |
| Infectious Diseases Clinical Hospital No. 1 | Recruiting | Moscow | Russia |
| Z.A. Bashlyaeva Children's City Clinical Hospital | Recruiting | Moscow | Russia |
| Penza Regional Clinical Center for Specialized Types of Medical Care | Recruiting | Penza | Russia |
| Children's Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency | Recruiting | Saint Petersburg | Russia |
| Samarkand State Medical University | Recruiting | Samarkand | Uzbekistan |