Efficacy of Pidotimod in the prevention of respiratory infections in healthy children.
- Conditions
- respiratory infections in children.Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2013-002273-22-IT
- Lead Sponsor
- Azienda Ospedaliera L. Sacco - Clinica Pediatrica
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Healthy children between 3- 4 years old
Caucasian race
Children who had never attended the kindergarten
Signed informed consent obtained from parents or legal guardian
Are the trial subjects under 18? yes
Number of subjects for this age range: 80
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
Being affected of a condition predisposing to recurrent respiratory infections such as immunological, neurological, renal, cardiovascular, hematological and neoplastic diseases, bronchodysplasia, Down syndrome and cystic fibrosis
Congenital anatomical abnormalities of the respiratory tract
Passive smoke exposure
Having at least one brother or sister attending the kindergarten
Known intolerance or allergy to Pidotimod
Assumption of an immunostimulant prior to study inclusion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of Pidotimod in reducing the rate of respiratory infections in healthy children.;Secondary Objective: To evaluate the duration of respiratory infections<br>To evaluate concomitant medications used during the study period (eg: antibiotics, systemic corticosteroids, antipyretics, antihistamines,mucolytics, antitussive and expectorant drugs)<br>To report the adverse effects of Pidotimod<br>To evaluate the number of episodes of caregiver absenteeism from work and lost school days in children<br>To evaluate the drug compliance;Primary end point(s): To evaluate the efficacy of Pidotimod in reducing the rate of respiratory infections in healthy children.;Timepoint(s) of evaluation of this end point: at the end of the study (7 months)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): To evaluate the duration of respiratory infections<br>To evaluate concomitant medications used during the study period (eg: antibiotics, systemic corticosteroids, antipyretics, antihistamines,mucolytics, antitussive and expectorant drugs)<br>To report the adverse effects of Pidotimod<br>To evaluate the number of episodes of caregiver absenteeism from work and lost school days in children<br>To evaluate the drug compliance;Timepoint(s) of evaluation of this end point: at each planned visit.