Immunodeficiency: primary or acquired
Background: At now, data on antibiotic prophylaxis in primary antibody deficiency patients are uncertain. We are studying the role of azithromycin on primary antibody deficiency patients. Methods: We are conducting a multi-center randomized placebo-controlled-double-blind trial on 89 patients with COPD and exacerbations. The aim of the study is evaluating efficacy and safety of azithomycin low-dose (250 mg 3 consecutive days a week) for 24 months vs placebo. In patients under azythomycin we expect a decrease of COPD exacerbations (reduction of dyspnea, cough, sputum), no use of additional antibiotics, an increase of respiratory volumes, an improvement of the Health Related Quality of Life measures. Results: The study started on June 2014 and will last 30 months (therapy: 24 months, follow-up: 6 months). Monthly evaluations: lung function, St. George's Respiratory Questionnaire, sputum sample for microbiological assessment, blood test, diaries for use of additional antibiotics, SF-36 Questionnaire for quality of life, report of adverse events. Our study will end on December 2016. During the study we observed 14 drop out (9 patients withdrew informed consent; 5 patients died: 2 for respiratory distress; 1 for cancer, 1 for Parkinson disease, 1 for stroke). Conclusion: To our knowledge our study is the first one on antibiotic prophylaxis in primary antibody deficiencies patients.