Reamberin® solution for infusion, 1.5 %
DrugReamberin® in daily dose 10 mL/kg
Recruiting
NCT Number: 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
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
1 year–6 year
Sex eligibility
All sexes
Study type
Observational
Primary location
South Ural State Medical University, Chelyabinsk, Russia
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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
Treatment and study plan
Primary outcomes
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Proportion of patients in groups who continued to receive infusion therapy 24 hours and 48 hours after the start of the treatment
Time frame: 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
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Average duration of infusion therapy in groups, expressed in days
Time frame: Day 10
Average duration of infusion therapy in groups, expressed in days
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Average durations of symptoms of damage of the gastrointestinal tract in groups
Time frame: Day 10
Average durations of symptoms of damage of the gastrointestinal tract (nausea, vomiting, diarrhea) in groups, expressed in days;
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Average duration of symptoms of intoxication in groups
Time frame: Day 10
Average duration of symptoms of intoxication (asthenia, lethargy, hypodynamia) in groups, expressed in days
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Share of patients in groups with moderate form and severe form 48 hours after the start of the treatment
Time frame: 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);
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Average duration of stay of patients in an inpatient healthcare facility
Time frame: Day 10
Average duration of stay of patients in an inpatient healthcare facility in treatment groups, expressed in days
Secondary outcomes
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Average volume of infusion therapy relative to body weight
Time frame: Day 10
Average volume of infusion therapy relative to body weight, expressed in milliliters
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Dynamics of intoxication symptoms after 24 hours and 48 hours
Time frame: 24 hours, 48 hours
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;
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Proportion of patients with electrolyte disturbances after 24 hours
Time frame: 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);
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Proportion of patients with base deficit (BE) less than 2 mmol/L after 24 hours
Time frame: 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);
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Dynamics of fever severity after 24 hours and 48 hours
Time frame: 24 hours, 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;
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Average duration of fever
Time frame: Day 10
Average duration of fever, expressed in days
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Average duration of stay in the ICU
Time frame: Day 10
Average duration of stay in the ICU (intensive care unit), expressed in hours (among patients transferred into ICU)
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Dynamics of symptoms of damage of the GI tract 24 hours and 48 hours
Time frame: 24 hours, 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;
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Dynamics of severity of dehydratation according to the CDS clinical scale 24 hours and 48 hours after the start of infusion therapy
Time frame: 24 hours, 48 hours
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;
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Dynamics of changes of parameters of complete blood count and leukocytic index of intoxication 24 hours and 48 hours
Time frame: 24 hours, 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).
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
POLYSAN Scientific & Technological Pharmaceutical Company
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jul 15, 2025
- Registry last updated
- Jul 15, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.