An observational study in Viral Enteric Infection, sponsored by POLYSAN Scientific & Technological Pharmaceutical Company. Recruiting at 8 sites in 2 countries. Open to participants aged 1 Year to 6 Years. Per ClinicalTrials.gov, last updated 2025-07-15.
Sponsored by POLYSAN Scientific & Technological Pharmaceutical Company · 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.
POLYSAN Scientific & Technological Pharmaceutical Company is the lead sponsor of 23 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children of both sexes at the age of 1-6 years old inclusive with viral enteric infection
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reamberin® in daily dose 10 mL/kg + normal saline (NaCl)/5 % or 10 % solution of glucose
Drug: Reamberin® solution for infusion, 1.5 %
Normal saline NaCl/Ringer's solution/5 % or 10 % solution of glucose
Reamberin® in daily dose 10 mL/kg
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
Time frame: 24 hours, 48 hours
Average duration of infusion therapy in groups, expressed in days
Average duration of infusion therapy in groups, expressed in days
Time frame: 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;
Time frame: Day 10
Average duration of symptoms of intoxication in groups
Average duration of symptoms of intoxication (asthenia, lethargy, hypodynamia) in groups, expressed in days
Time frame: 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);
Time frame: 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
Time frame: Day 10
Average volume of infusion therapy relative to body weight
Average volume of infusion therapy relative to body weight, expressed in milliliters
Time frame: Day 10
Dynamics of intoxication symptoms after 24 hours and 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;
Time frame: 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);
Time frame: 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);
Time frame: 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;
Time frame: 24 hours, 48 hours
Average duration of fever
Average duration of fever, expressed in days
Time frame: 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)
Time frame: 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;
Time frame: 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;
Time frame: 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).
Time frame: 24 hours, 48 hours
Started Aug 2024 (actual). Primary completion is estimated for Jun 2026, 22 months after the start.
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