Children of both sex between 2-5 years old, already socialized or to be socialized (nursery school or preschool) in the following three months after been included in the study. MedDRA version: 9.1 Level: LLT Classification code 10057868 Term: Upper respiratory tract infection bacterial
Conditions
Interventions
Trade Name: IMMUCYTAL
Pharmaceutical Form: Granules
INN or Proposed INN: RIBOSOMAL/KLEBSPROTINA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .525-
Pharmaceutica
Sponsors
PIERRE FABRE PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children of both sex between 2-5 years old, already socialized or to be socialized (nursery school or preschool) in the following three months after been included in the study. 2. Absence of malformations and/or clinically significant pathologies in progress. 3. Parents (o legal guardians) and/or children who are able to understand and follow what the study protocol demands Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any RRI episode in the 7 days prior randomization 2. Infective and non infective acute episodes in progress during randomization in any body system which require hospital recovery and/or intensive therapy 3. Gastroesophageal reflux 4. Cistic Fibrosis, deficit of α 1-antitrypsin, ciliary dyskinesia 5. Severe and chronic pathologies in any body system. 6. Corporal mass less than 3rd percentile of the respective age. 7. Autoimmune disease carrier. 8. Any product belonging to the groups ATC J06 (immune serum and immunoglobulins) or J07AX (immunostimulants) two weeks before the recruitment. 9. Treated two weeks prior the recruitment or presumed necessity of treatment for the entire period of study (including the follow up period) with: Immunostimulants belonging to the group J07AX ATC; Antineoplastic drugs belonging to the group L01 ATC; Drugs belonging to the groups L03 and L04 ATC like cytokines, interleukins, interferon, immunosoppressors; systemic corticosteroids; pharmaceutical products or food supplies who?s ingredients contain zinc; any ethical, over the counter, herboristic (eg. echinacea) or homeopathic product that have immunonostimulant properties as one of their indications. 10. History of allergy or intolerance to the studied products and/or one of the excipients 11. Parents (or legal guardians) and/or patients that can?t understand the information given in order to obtain informed consent or that refuse to give a written informed consent due to linguistic or psychological factors. 12. Parents (or legal guardians) that have lost the guardianship. 13. Parents (or legal guardians) and/or patients that can?t be contacted during the study. 14. Participation to other clinical studies within a month prior or during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation after 6 months of the effects, vs placebo, of the treatment with Biomunil / Immucytal administrated at the dosage described in the SPC, on the overall duration of the infective episodes.;Secondary Objective: Evaluation, vs placebo, of the effects of the treatment of Biomunil/Immucytal on: 1. Number of IRR episodes (at 6 and at12 months); 2. Overall duration, of infective episodes vs. placebo (at 12 months); 3. Frequency and severity of the episodes, aggregated into clusters of frequency and diagnosis (at 6 and at 12 months); 4. Overall duration of the episodes (at 6 and at 12 months); 5. Onset time of first episode after the end of the treatment; 6. Use of drugs and of other assistance services (at 6 and at 12 months); 7. Absence from the community (at 6 and at 12 months); 8. Time off work for parents and/or need to contact a babysitter (at 6 and at 12 months); 9. Safety and tolerability; 10. Evaluation by parents (health) and by physicians (efficacy, safety).;Primary end point(s): The primary endpoint of efficacy will be the overall duration of infective episodes, expressed in days, observed 6 months after the start of the treatment with Biomunil/Immucytal adminsitrated at the doses described in the SPC. | — |
Countries
Italy
Outcome results
None listed