Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children
Condition: Acute Upper Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Intervention: Ergoferon; Placebo
Intervention description: Safety and Efficiency of liquid dosage form; Safety and Efficiency of liquid dosage form
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 306.0
Sex: All
Minimum age: 3 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is:

        -  to assess safety of the liquid dosage form of Ergoferon for treatment of acute upper
           respiratory tract infections in children;

        -  to assess clinical efficacy of the liquid dosage form of Ergoferon for treatment acute
           upper respiratory tract infections in children.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients of both sexes aged over 3 years and under 18 years.

          2. Patients who consulted a doctor within 24 hours after the onset of acute respiratory
             infection (body temperature no less than 38.0°C when visiting a doctor + intensity of
             symptoms ≥ 4 scores (presence of at least 1 general symptom ≥ 2 scores and 1 nasal/
             throat/ chest symptom ≥ 2 scores or greater number of symptoms with the intensity≥1
             score) during seasonal morbidity.

          3. The possibility to start therapy within 24 hours after the onset of the first symptoms
             of acute respiratory infection.

          4. Usage of contraceptive methods by sexually active teenagers of both sexes during the
             trial and within 30 days after ending of the participation in the trial.

          5. Availability of information sheet (Informed Consent form) for parents/adopters of
             patient for participation in the clinical trial, Version 2.1 or Version 2.2, signed by
             one parent/adopter of patient. For patients over 14 years - availability of
             information sheet (Informed Consent form) for participation in the clinical trial,
             Version 2.1 or Version 2.2, signed by a patient and one parent/adopter of patient.

        Exclusion Criteria:

          1. Suspected bacterial infection or presence of a severe disease requiring use of
             antibacterial drugs (including sulfanilamides).

          2. Suspected initial manifestations of diseases that have symptoms similar to acute
             respiratory infection (other infectious diseases, influenza-like syndrome at the onset
             of systemic connective tissue disorders, oncohematology and other pathology).

          3. Medical history of primary and secondary immune deficiency: a) lymphoid system
             immunodeficiency (T-cell and /or B-cell immunity chain, immunodeficiency with
             predominant antibody deficiency); b) phagocyte deficiency; c) complement factors
             deficiency; d ) combined immunodeficiency including AIDS induced by HIV infection;
             toxic, autoimmune, infectious, radial panleukopenia syndrome; general lymphocytopenia
             syndrome; syndrome of lymphocyte polyclonal activation; postsplenectomia syndrome;
             congenital asplenia; syndrome of immune complexes pathology associated with
             infectious, allergic and autoimmune diseases.

          4. Medical history of sarcoidosis.

          5. Oncological diseases.

          6. Exacebration or decompensation of chronic diseases affecting the patient's ability to
             participate in the clinical trial.

          7. Medical history of polyvalent allergy.

          8. Allergy/ intolerance to any of the components of medications used in the treatment.

          9. Impaired glucose tolerance, diabetes mellitus.

         10. Hereditary fructose intolerance (as the study drug contains maltitol).

         11. Intake of medicines listed in the section "Prohibited concomitant treatment" for 1
             month prior to the inclusion in the trial.

         12. Pregnancy, unwillingness of sexually active female patients to use of contraceptive
             methods during the study.

         13. Drug addiction, alcohol usage in the amount 2 units of alcohol per day on the part of
             patient's parents/adopters.

         14. Mental disorders of patient or of patient's parents/adopters.

         15. Patient's parents/ adopters, who from investigator's point of view, will fail to
             comply with the observation requirements of the trial or with the intake regimen of
             the investigated medicines.

         16. Participation in other clinical trials in the course of 3 months prior to the
             inclusion in the trial.

         17. Patient's parent/adopter is related to the research personnel of the investigative
             site, who are directly involved in the trial or are the immediate relative of the
             researcher. The immediate relatives includes husband/wife, parents, children or
             brothers (or sisters), regardless of whether they are natural or adopted.

         18. Patient's parent/adopter works for OOO "NPF "Materia Medica Holding" (i.e. is the
             company's employee, temporary contract worker or appointed official responsible for
             the carrying out the research) or the immediate relative.