AZITHROMYCIN IN BRONCHIOLITIS OBLITERANS SYNDROME - AZI001

Phase 1

• Conditions: - Chronic rejection at 1 and 2 year post-lung transplantation- Mortality at 1 and 2 year post-lung transplantation- Acute rejection rate at 1 and 2 post-lung transplantation- Infection rate at 1 and 2 year post-lung transplantation- Evolution of airway inflammation and pulmonary function during the first and second year post-lung transplantation; MedDRA version: 12.0Level: LLTClassification code 10029888Term: Obliterative bronchiolitis; MedDRA version: 12.0Level: LLTClassification code 10049202Term: Bronchiolitis obliterans; MedDRA version: 12.0Level: LLTClassification code 10068805Term: Follicular bronchiolitis; MedDRA version: 12.0Level: LLTClassification code 10019319Term: Heart-lung transplant rejection; MedDRA version: 12.0Level: LLTClassification code 10025127Term: Lung transplant; MedDRA version: 12.0Level: LLTClassification code 10050433Term: Prophylaxis against lung transplant rejection; MedDRA version: 12.0Level: LLTClassification code 10050437Term: Prophylaxis against heart and lung transplant rejection; MedDRA version: 12.0Level: LLTClassification code 10051604Term: Lung transplant rejection; MedDRA version: 12.0Level: LLTClassification code 10056409Term: Heart and lung transplant

• Registration Number: EUCTR2005-003893-46-BE
• Lead Sponsor: KULeuven and University Hospitals Leuven (Leuven Lung Transplant Group)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-21
• Study Completion: 2010-12-28
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - Prevalence of chronic rejection at 1 and 2 year post-transplant<br>- Overall survival at 1 and 2 year post-transplant<br>;Secondary Objective: - Acute rejection rate at 1 and 2 year post-transplant<br>- Infection rate at 1 and 2 year post-transplant<br>- Evolution of pulmonary function (FEV1 and FEF25-75) during the first and second year after transplantation<br>- Evolution of BAL cellularity, protein levels (e.g. IL-8, IL-17) and microbiology (e.g. <br> Chlamydia, Mycoplasma, Pseudomonas species or other bacterial or viral colonisations) during the first and second year after transplantation<br>;Primary end point(s): - Prevalence of chronic rejection at 1 and 2 year post-transplant<br>- Overall survival at 1 and 2 year post-transplant<br>