Randomized Double-blind Placebo-controlled Prevention Trial of Azithromycin in Lung Transplantation.
Overview
- Phase
- Phase 4
- Intervention
- Azithromycin
- Conditions
- Bronchiolitis Obliterans Syndrome
- Sponsor
- KU Leuven
- Enrollment
- 83
- Locations
- 1
- Primary Endpoint
- Prevalence of Bronchiolitis Obliterans Syndrome (BOS)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Stable LTx recipients at discharge after transplantation.
- •Signed informed consent
- •Adult (age at least 18 years old at moment of transplantation)
- •Able to take oral medication
Exclusion Criteria
- •Prolonged and/or complicated ICU-course after transplantation.
- •Early (\<30 days post-transplant) post-operative death
- •Major suture problems (airway stenosis or stent)
- •Retransplantation (lung)
- •Previous transplantation (solid organ)
- •Multi-organ transplantation (lung+ other solid organ)
Arms & Interventions
Azithromycin
250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
Intervention: Azithromycin
Placebo
PLacebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
Intervention: Placebo
Outcomes
Primary Outcomes
Prevalence of Bronchiolitis Obliterans Syndrome (BOS)
Time Frame: 2 years post-transplant
BOS was defined as a sustained decrease in forced Expiratory Volume in one second (FEV1) of at least 20% from the patient's maximum post-operative values in the absence of other causes.
Overall Survival
Time Frame: 2 years post-transplant
Survival data were obtained using all-cause mortality information in the Leuven University Hospital transplant database, in which all our lung transplant recipients since 1991 are registered. For the end-point of all-cause mortality, survival times were not censored at retransplantation or at study-discontinuation if these preceded death, or else at 2 years after transplantation.
Secondary Outcomes
- Acute Rejection Incidence Rate(2 years post-transplant)
- Infection Incidence Rate(2 years post-transplant)
- Pulmonary Function(during first two years post-transplant)
- Broncho-alveolar (BAL) Neutrophilia(during first two years post-transplant)
- Plasma C-reactive Protein (CRP) Levels(during the first two years post-transplant)