Impact of azithromycin as an immunomodulator in patients with recurrent pneumonia and deficit of mannose-binding LECITHIN (MBL2012)

INTERVENTION: 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: AZITHROMYCIN DIHYDRATE Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 40‐500 Pharmaceutical form of the placebo: Pour‐on suspension Route of administration of the placebo: Oral use CONDITION: 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 Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] PRIMARY OUTCOME: 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. Primary end point(s): Quantification of inflammatory markers (IL‐6, IL‐8, TNF‐?). 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. Timepoint(s) of evaluation of this end point: The inflammatory markers were quantified at baseline (azithromycin vs. placebo) and 3 months of it. SECONDARY OUTCOME: 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. 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 <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