Conditions: Bronchiolitis Obliterans Syndrome Graft Rejection Lymphocytic Bronchiolitis Respiratory Infection
Keywords: Bronchiolitis Obliterans Syndrome Acute allograft Rejection Lymphocytic bronchiolitis Respiratory infection Survival Mortality Pulmonary function FEV1 Broncho-alveolar lavage Neutrophils Interleukin Culture Azithromycin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 83
Healthy volunteers: no

Brief summary:
Preventive treatment with azithromycin reduces the prevalence fo Bronchiolitis Obliterans Syndrome after lung transplantation.

Detailed description:
* Prospective, interventional, randomized, double-blind, placebo-controlled trial.
* Clinical setting (tertiary University Hospital).
* Investigator-driven, no pharmaceutical sponsor.
* Lung transplant recipients.
* Add-on of study-drug (placebo or azithromycin) to 'standard of care' (standardized, routine immunosuppressive and infectious prophylactic protocol).
* 1:1 inclusion ratio (placebo:azithromycin).
* Randomisation at discharge after informed consent.

Arms:
arm 1: 250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study arm 2: PLacebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.

Interventions: intervention 1: Azithromycin intervention 2: Placebo
Intervention descriptions: intervention 1: Azithromycin 250 mg daily during 5 days followed by 250 mg three times a week on Mon., Wed. and Fri. during study-period. intervention 2: Placebo once daily during 5 days, followed by one placebo three times a week on Mon., Wed. and Fri during rest of study-period.

Protocol document: