Viral Enteric InfectionNCT07066540
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
An observational study of Viral Enteric Infection, run by POLYSAN Scientific & Technological Pharmaceutical Company at 8 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Viral Enteric Infection
- What is being tested?
- Reamberin® solution for infusion, 1.5 %
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Aug 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children of both sexes at the age of 1-6 years old inclusive with viral enteric infection
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
Russia7 sites, 7 recruiting
- Recruiting
South Ural State Medical University
Chelyabinsk
- Recruiting
Khimki Clinical Hospital
Khimki
- Recruiting
Kuban State Medical University
Krasnodar
- Recruiting
Infectious Diseases Clinical Hospital No. 1
Moscow
- Recruiting
Z.A. Bashlyaeva Children's City Clinical Hospital
Moscow
- Recruiting
Penza Regional Clinical Center for Specialized Types of Medical Care
Penza
- Recruiting
Children's Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency
Saint Petersburg
Uzbekistan1 site, 1 recruiting
- Recruiting
Samarkand State Medical University
Samarkand
About this study
Official 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
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.
- Conditions
- Viral Enteric Infection
- Being tested
- Reamberin® solution for infusion, 1.5 %
- Keywords
- viral enteric infection, reamberin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reamberin® solution for infusion, 1.5 %Drug
Reamberin® in daily dose 10 mL/kg
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Reamberin® in daily dose 10 mL/kg + normal saline (NaCl)/5 % or 10 % solution of glucose Receives: Drug: Reamberin® solution for infusion, 1.5 % | |
| Control group | Normal saline NaCl/Ringer's solution/5 % or 10 % solution of glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours, 48 hours
Average duration of infusion therapy in groups, expressed in days
Average duration of infusion therapy in groups, expressed in days
Measured: 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;
Measured: Day 10
Average duration of symptoms of intoxication in groups
Average duration of symptoms of intoxication (asthenia, lethargy, hypodynamia) in groups, expressed in days
Measured: 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);
Measured: 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
Measured: Day 10
Secondary outcomes (10)
Average volume of infusion therapy relative to body weight
Average volume of infusion therapy relative to body weight, expressed in milliliters
Measured: 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;
Measured: 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);
Measured: 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);
Measured: 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;
Measured: 24 hours, 48 hours
Average duration of fever
Average duration of fever, expressed in days
Measured: 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)
Measured: 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;
Measured: 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;
Measured: 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).
Measured: 24 hours, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Aug 2024
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral Enteric InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066540
- Sponsor's protocol ID
- REAMBERIN-05-2022
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07066540
- Acronym / sponsor ID
- REAMBERIN-05-2022
- Conditions
- Viral Enteric Infection
- Keywords
- viral enteric infection, reamberin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Drug: Reamberin® solution for infusion, 1.5 %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 |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children of both sexes at the age of 1-6 years old inclusive with viral enteric infection
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reamberin® solution for infusion, 1.5 %Reamberin® in daily dose 10 mL/kg | Drug | Treatment group |
Primary outcome
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
Average duration of infusion therapy in groups, expressed in days
Time frame: Day 10
Average duration of infusion therapy in groups, expressed in days
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;
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
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);
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
10 secondary outcomes
Average volume of infusion therapy relative to body weight
Time frame: Day 10
Dynamics of intoxication symptoms after 24 hours and 48 hours
Time frame: 24 hours, 48 hours
Proportion of patients with electrolyte disturbances after 24 hours
Time frame: 24 hours
Proportion of patients with base deficit (BE) less than 2 mmol/L after 24 hours
Time frame: 24 hours
Dynamics of fever severity after 24 hours and 48 hours
Time frame: 24 hours, 48 hours
Average duration of fever
Time frame: Day 10
Average duration of stay in the ICU
Time frame: Day 10
Dynamics of symptoms of damage of the GI tract 24 hours and 48 hours
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
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
Time frame: 24 hours, 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
Related trials for Viral Enteric Infection
Active, not recruiting
Wells and Enteric Disease Transmission
Diarrhea, Gastrointestinal Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Viral Enteric Infection, run by POLYSAN Scientific & Technological Pharmaceutical Company at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Russia, Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexey Kovalenko, Doc Biol Sci (+78127108225 Ext. 212, science@polysan.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.