Clinical trial of the efficacy and tolerability of an immunostimulant drug, composed by ribosomal fractions, in socialized paediatric patients in order to prevent recurrent respiratory infections. A randomized, double -blind vs. placebo, multicentric study. - ND

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10057868Term: Upper respiratory tract infection bacterial; 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.

• Registration Number: EUCTR2008-000487-17-IT
• Lead Sponsor: PIERRE FABRE PHARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified