Recruiting 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
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Reamberin® solution for infusion, 1.5 %.
- Who it may be relevant to
- Registry conditions: Viral Enteric Infection. Basic parameters: 1 year — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia, Uzbekistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
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.
Interventions
- Drug Reamberin® solution for infusion, 1.5 %
Reamberin® in daily dose 10 mL/kg
Primary outcome measures
- 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]
- 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 [Time frame: Day 10]
- Average duration of symptoms of intoxication in groups [Time frame: Day 10]
- Share of patients in groups with moderate form and severe form 48 hours after the start of the treatment [Time frame: 48 hours]
- Average duration of stay of patients in an inpatient healthcare facility [Time frame: Day 10]
Secondary outcome measures (10)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Russia · 7 centers
- South Ural State Medical University — Chelyabinsk
- Khimki Clinical Hospital — Khimki
- Kuban State Medical University — Krasnodar
- Infectious Diseases Clinical Hospital No. 1 — Moscow
- Z.A. Bashlyaeva Children's City Clinical Hospital — Moscow
- Penza Regional Clinical Center for Specialized Types of Medical Care — Penza
- Children's Scientific and Clinical Center for Infectious Diseases of the Federal Medical a — Saint Petersburg
Uzbekistan · 1 center
- Samarkand State Medical University — Samarkand
Identifiers
NCT: NCT07066540 · REAMBERIN-05-2022