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

NCT07066540 | Recruiting

• 1 other identifier: REAMBERIN-05-2022
• Study Type: observational
• Target: 300
• Locations: 2 countries
• Sites: 8

Brief 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. Trial population: children of both sexes at the age of 1-6 years old inclusive with viral enteric infection.

Conditions

Viral Enteric Infection

Keywords

viral enteric infection; reamberin

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (10)

• 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

Study Arms (2)

Treatment group

Reamberin® in daily dose 10 mL/kg + normal saline (NaCl)/5 % or 10 % solution of glucose

Drug: Reamberin® solution for infusion, 1.5 %

Control group

Normal saline NaCl/Ringer's solution/5 % or 10 % solution of glucose

Interventions

Reamberin® solution for infusion, 1.5 % DRUG

Reamberin® in daily dose 10 mL/kg

Treatment group

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children of both sexes at the age of 1-6 years old inclusive with viral enteric infection

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• POLYSAN Scientific & Technological Pharmaceutical Company: lead

Study Sites (8)

South Ural State Medical University

Chelyabinsk, Russia

RECRUITING

Khimki Clinical Hospital

Khimki, Russia

RECRUITING

Kuban State Medical University

Krasnodar, Russia

RECRUITING

Infectious Diseases Clinical Hospital No. 1

Moscow, Russia

RECRUITING

Z.A. Bashlyaeva Children's City Clinical Hospital

Moscow, Russia

RECRUITING

Penza Regional Clinical Center for Specialized Types of Medical Care

Penza, Russia

RECRUITING

Children's Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency

Saint Petersburg, Russia

RECRUITING

Samarkand State Medical University

Samarkand, Uzbekistan

RECRUITING

Central Study Contacts

Alexey Kovalenko, Doc Biol Sci

CONTACT

+78127108225 Ext. 212; science@polysan.ru

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: July 15, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-05

Locations

RU (7); UZ (1)