NCT01009619

Azithromycin in Bronchiolitis Obliterans Syndrome

Randomized Double-blind Placebo-controlled Prevention Trial of Azithromycin in Lung Transplantation.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bronchiolitis Obliterans Syndrome
• Graft Rejection
• Lymphocytic Bronchiolitis
• Respiratory Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2005-09-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-11-09
• Last updated: 2011-10-03
• Results posted: 2011-08-25

Locations

1 site across 1 country: Belgium