Pediatric patients with recurrent pneumonia and MBL deficiency. MedDRA version: 15.1 Level: PT Classification code 10061598 Term: Immunodeficiency System Organ Class: 10021428 - Immune system disorders MedDRA version: 15.1 Level: LLT Classification code 10010120 Term: Community acquired pneumonia System Organ Class: 100000004862
Conditions
Interventions
Trade Name: AZITROMICINA KERN PHARMA
Product Name: azitromicina
Pharmaceutical Form: Pour-on solution
INN or Proposed INN: AZITHROMYCIN DIHYDRATE
CAS Number: 117772-70-0
Other descriptive name: AZITHR
Sponsors
Fundación Pública Andaluza para la Gestion de la Investigación en Salud de Sevilla
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the role of azithromycin as an immunomodulator of the inflammatory response in pediatric patients with recurrent pneumonia and MBL deficiency, analyzing the role of the antibiotic in the expression of MBL receptor (CDw93) and evaluate the significance of their use in practice daily clinical practice. Quantify plasma inflammatory markers (IL-6, IL-8, TNF-?) before the start of treatment (azithromycin vs. placebo) and 3 months of it.;Secondary Objective: To assess the rate of pneumonia presenting our patients during the 3 months of treatment (azithromycin vs. placebo) and 6 months of the suspension. Analyze the days of hospitalization, days of consultations in emergency services, school absenteeism (days per month does not go to school) and labor (days per month that parents do not go to work) during the 3 months of treatment (azithromycin vs placebo) and 6 months of suspension.;Primary end point(s): Quantification of inflammatory markers (IL-6, IL-8, TNF-?).;Timepoint(s) of evaluation of this end point: The inflammatory markers were quantified at baseline (azithromycin vs. placebo) and 3 months of it. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the rate of pneumonia and Analyze the days of hospitalization, days of consultations in emergency services, school absenteeism (days per month does not go to school) and labor (days per month that parents do not go to work) during the 3 months of treatment (azithromycin vs placebo) and 6 months of suspension.;Timepoint(s) of evaluation of this end point: 3 months of treatment (azithromycin vs. placebo) and 6 months of the suspension. | — |
Countries
Spain
Contacts
Public ContactClara M. Rosso Fernandez
FISEVI-Hospital Virgen del Rocio
Outcome results
None listed