Official Title: “Randomized Double-blind Placebo-controlled Prevention Trial of Azithromycin in Lung Transplantation.”

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

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment

Study Primary Completion Date: December 2009

- 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.

Intervention(s) in this Clinical Trial

• Drug: Azithromycin
  • Azithromycin 250 mg daily during 5 days followed by 250 mg three times a week on Mon., Wed. and Fri. during study-period.
• Drug: Placebo
  • Placebo once daily during 5 days, followed by one placebo three times a week on Mon., Wed. and Fri during rest of study-period.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Azithromycin
  • 250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
• Placebo Comparator: Placebo
  • PLacebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.

Primary Measures

• Prevalence of Bronchiolitis Obliterans Syndrome
  • Time Frame: at 1 and 2 years post-transplant
    Safety Issue?: No
• Overall survival
  • Time Frame: at 1 and 2 years post-transplant
    Safety Issue?: No

Secondary Measures

• Acute rejection rate
  • Time Frame: at 1 and 2 years post-transplant
    Safety Issue?: No
• Infection rate
  • Time Frame: at 1 and 2 years post-transplant
    Safety Issue?: No
• Pulmonary function evolution
  • Time Frame: during first and second year post-transplant
    Safety Issue?: No
• Evolution of BAL cellularity, protein levels and microbiology
  • Time Frame: during first and second year post-transplant
    Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Katholieke Universiteit Leuven

Overall Clinical Trial Officials and Contacts

Geert M Verleden, Prof. Dr. Principal Investigator KULeuven and University Hospitals Leuven  

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01009619

Study ID Number: AZI001

ClinicalTrials.gov Identifier: NCT01009619

Health Authority: European Union: European Medicines Agency