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

POLYSAN Scientific & Technological Pharmaceutical Company300 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Viral Enteric Infection

Interventions

Reamberin® solution for infusion, 1.5 %DRUG

Reamberin® in daily dose 10 mL/kg

Eligibility

Sex: ALLMin age: 1 YearMax age: 6 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Children of both sexes at the age of 1 to 6 years old inclusive; 2. 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), 3. Clinical signs of endogenous intoxication (nausea, vomiting, hyperthermia, headache, muscle pain, asthenia, adynamia, etc.); 4. Indication for parenteral rehydratation (infusion therapy); 5. 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; 6. To confirm the diagnosis by laboratory tests, biological material was taken; 7. Informed Consent Form on Participation in the Observational Program signed and dated by a parent/legal representative of the patient. Exclusion Criteria: 1. 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; 2. Contraindications to prescription of drug product Reamberin®; 3. Necessity in surgical interventions during the observational program; 4. Patients previously enrolled in this trial but discontinued participation due to any any reason; 5. Administration of antibiotics or succinate-containing drug products (Cytoflavin, Mexidol, etc.) and solutions containing malate; 6. 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

Locations (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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

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

Overview

Conditions

Interventions

Eligibility

Locations (8)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts