Clinical trial NCT01009619: Azithromycin in Bronchiolitis Obliterans Syndrome
Official title: Randomized Double-blind Placebo-controlled Prevention Trial of Azithromycin in Lung Transplantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: University Hospital, Gasthuisberg
name: Fund for Scientific Research, Flanders, Belgium
First posted: 2009-11-09
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Prevalence of Bronchiolitis Obliterans Syndrome (BOS)
timeFrame: 2 years post-transplant
measure: Overall Survival
timeFrame: 2 years post-transplant
Secondary outcomes:
measure: Acute Rejection Incidence Rate
timeFrame: 2 years post-transplant
measure: Infection Incidence Rate
timeFrame: 2 years post-transplant
measure: Pulmonary Function
timeFrame: during first two years post-transplant
measure: Broncho-alveolar (BAL) Neutrophilia
timeFrame: during first two years post-transplant
measure: Plasma C-reactive Protein (CRP) Levels
timeFrame: during the first two years post-transplant
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven and University Hospital Gasthuisberg
Study officials:
affiliation: KULeuven and University Hospitals Leuven
name: Geert M Verleden, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruttens D, Verleden SE, Vandermeulen E, Bellon H, Vanaudenaerde BM, Somers J, Schoonis A, Schaevers V, Van Raemdonck DE, Neyrinck A, Dupont LJ, Yserbyt J, Verleden GM, Vos R. Prophylactic Azithromycin Therapy After Lung Transplantation: Post hoc Analysis of a Randomized Controlled Trial. Am J Transplant. 2016 Jan;16(1):254-61. doi: 10.1111/ajt.13417. Epub 2015 Aug 4.
citation: Vos R, Vanaudenaerde BM, Verleden SE, De Vleeschauwer SI, Willems-Widyastuti A, Van Raemdonck DE, Schoonis A, Nawrot TS, Dupont LJ, Verleden GM. A randomised controlled trial of azithromycin to prevent chronic rejection after lung transplantation. Eur Respir J. 2011 Jan;37(1):164-72. doi: 10.1183/09031936.00068310. Epub 2010 Jun 18.