Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Viral Intestinal Infections in Children
Condition: Viral Intestinal Infection
MeSH terms: Infections; Communicable Diseases
Intervention: Ergoferon; Placebo
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 259.0
Sex: All
Minimum age: 6 Months
Maximum age: 6 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to obtain additional data on efficacy and safety of Ergoferon in
      the treatment of viral intestinal infections in inpatient children.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients of both gender aged from 6 months to 6 years, who have been admitted to
             infectious diseases unit.

          2. Diarrhea (watery diarrhea at least 3 times a day).

          3. CDS score of ≥1.

          4. The first 48 hours from the onset of the first diarrhea episode.

          5. Start of study treatment (Ergoferon/Placebo) within 12 hours after the start of the
             standard hospital therapy.

          6. Availability of a patient information sheet (Informed Consent form) signed by the
             patient's parents/adopters to confirm the child's participation in the clinical trial
             signed by one parent/adopter of the patient.

        Exclusion Criteria:

          1. Suspected bacterial intestinal infection.

          2. Suspected infectious diseases affecting other organ systems (e.g. pneumonia,
             meningitis, sepsis, otitis media, urinary tract infection, etc.).

          3. Severe intestinal infection.

          4. Severe dehydration (CDS score ≥7).

          5. Anuria (acute kidney injury).

          6. Medical history or prior diagnosis of serious diseases, including primary/secondary
             immunodeficiency, oncological disease, diabetes mellitus, infantile cerebral palsy,
             mucoviscidosis/cystic fibrosis etc.

          7. Exacerbation, or decompensation of chronic disease, including diseases of the
             digestive system that would affect the patient's ability to participate in the
             clinical trial.

          8. Malabsorption syndrome, including congenital or acquired lactose intolerance/lactase
             deficiency or any other disaccharidase deficiency and galactosemia.

          9. Allergy/ intolerance to any of the components of medications used in the treatment.

         10. Course intake of medicines listed in the section "Prohibited concomitant treatment"
             for 2 weeks prior to the enrollment in the trial.

         11. Participation in other clinical trials within 3 months prior to the enrollment in this
             study.

         12. Patients whose parents/adopters, from the investigator's point of view, will fail to
             comply with the observation requirements of the trial or with the dosing regimen of
             the study drugs.

         13. Patient's parents/adopters are related to the research staff of the clinical
             investigative site who are directly involved in the trial or are the immediate family
             member of the researcher. The immediate family members include husband/wife, parents,
             children or brothers (or sisters), regardless of whether they are natural or adopted.

         14. The patient's parent/adopter works for MATERIA MEDICA HOLDING (i.e., is the company's
             employee, temporary contract worker or appointed official responsible for carrying out
             the research) or the immediate relative.