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Efficacy of Pidotimod in the prevention of respiratory infections in healthy children.

Efficacy of Pidotimod in the prevention of respiratory infections in healthy children: a randomized, double blind, placebo controlled study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-002273-22-IT
Enrollment
Unknown
Registered
2013-07-03
Start date
2013-07-24
Completion date
Unknown
Last updated
2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory infections in children.

Interventions

Trade Name: AXIL 400 mg/7 ml soluzione orale Product Name: Pidotimod Pharmaceutical Form: Oral solution in single-dose container Pharmaceutical form of the placebo: Oral solution in single-dose contai

Sponsors

Azienda Ospedaliera L. Sacco - Clinica Pediatrica
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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 To evaluate concomitant medications used during the study period (eg: antibiotics, systemic corticosteroids, antipyretics, antihistamines,mucolytics, antitussive and expectorant drugs) To report the adverse effects of Pidotimod To evaluate the number of episodes of caregiver absenteeism from work and lost school days in children 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

MeasureTime frame
Secondary end point(s): To evaluate the duration of respiratory infections To evaluate concomitant medications used during the study period (eg: antibiotics, systemic corticosteroids, antipyretics, antihistamines,mucolytics, antitussive and expectorant drugs) To report the adverse effects of Pidotimod To evaluate the number of episodes of caregiver absenteeism from work and lost school days in children To evaluate the drug compliance;Timepoint(s) of evaluation of this end point: at each planned visit.—

Countries

Italy

Contacts

Public ContactClinica Pediatrica

Azienda Ospedaliera L. Sacco

gianvincenzo.zuccotti@unimi.it00390239042253

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026