The role of azithromycin in patients with recurrent pneumonia and immunodeficiency
- Conditions
- Pediatric patients with recurrent pneumonia and MBL deficiency.MedDRA version: 15.1Level: PTClassification code 10061598Term: ImmunodeficiencySystem Organ Class: 10021428 - Immune system disordersMedDRA version: 15.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2012-001766-15-ES
- Lead Sponsor
- Fundación Pública Andaluza para la Gestion de la Investigación en Salud de Sevilla
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
A. - Patient greater than six months and less than 14 years.
2. - Patients with NR, ie, at least two pneumonic episodes observed radiologically in an interval of one year or three episodes at any time in his life, whenever there is radiological normalization between episodes.
3. - Patient with MBL deficiency, ie serum MBL levels <500 ng / ml.
4. - Patients whose parents or guardians accept their participation in the study by signing an informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
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
1. - Patients with other associated immunodeficiencies.
2. - Patients with other lung diseases, heart disease or cancer processes.
3. - Patients with allergies to azitromicine, other macrolides or any excipients of the formulation.
4. - Patients treated with other drugs that may interact with macrolides.
5. - Patients with long QT for age.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method