Azithromycin in bronchiolitis obliterans syndrome

ISRCTN	ISRCTN36220396
DOI	https://doi.org/10.1186/ISRCTN36220396
ClinicalTrials.gov (NCT)	NCT01009619
Clinical Trials Information System (CTIS)	2005-003893-46
Protocol serial number	AZI001
Sponsor	Katholieke Universiteit Leuven and University Hospitals Leuven (Belgium) - Lab of Pneumology, Lung Transplant Unit
Funder	Katholieke Universiteit Leuven and University Hospitals Leuven (Belgium) - Lab of Pneumology, Lung Transplant Unit

Submission date: 05/11/2009
Registration date: 17/12/2009
Last edited: 22/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Geert M Verleden
Scientific

49 Herestraat
Leuven
B-3000
Belgium

Phone	+32 (0)16 34 68 08
Email	geert.verleden@uzleuven.be

Study information

Primary study design	Interventional
Study design	Prospective interventional randomised double-blind placebo-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised, double-blind, placebo-controlled trial of azithromycin in lung transplantation
Study objectives	Preventive treatment with azithromycin can reduce the prevalence of bronchiolitis obliterans syndrome after lung transplantation.
Ethics approval(s)	Local Ethical Board (Commissie Medische Ethiek UZ KULeuven), 06/07/2005
Health condition(s) or problem(s) studied	Bronchiolitis obliterans syndrome
Intervention	Add-on of study-drug (over-encapsulated placebo or azithromycin) to 'standard of care'. Study-drug regime: 250 mg daily for 5 days, followed by 250 mg every other day until the end of the study-period. Matching placebo regimen.
Intervention type	Drug
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Azithromycin
Primary outcome measure(s)	1. Prevalence of bronchiolitis obliterans syndrome at 1 and 2 year post-transplant 2. Overall survival at 1 and 2 year post-transplant
Key secondary outcome measure(s)	1. Acute rejection rate at 1 and 2 year post-transplant 2. Infection rate at 1 and 2 year post-transplant 3. Evolution of pulmonary function during the first and second year after transplantation 4. Evolution of bronchoalveolar lavage (BAL) cellularity, protein levels and microbiology during the first and second year after transplantation
Completion date	28/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	80
Key inclusion criteria	1. Stable LTx recipients at discharge after transplantation 2. Signed informed consent 3. Adult of either sex (aged at least 18 years old at moment of transplantation) 4. Able to take oral medication
Key exclusion criteria	1. Prolonged and/or complicated intensive care unit (ICU) course after lung transplantation 2. Early (less than 30 days post-transplant) post-operative death 3. Major suture problems (airway stenosis or stent) 4. Retransplantation (lung) 5. Previous transplantation (solid organ) 6. Multi-organ transplantation (lung and other solid organ)
Date of first enrolment	01/09/2005
Date of final enrolment	28/12/2010

Locations

Countries of recruitment

Belgium

Study participating centre

49 Herestraat

Leuven
B-3000
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2011		Yes	No
Basic results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

22/03/2016: added link to results - basic reporting.

On 10/01/2010 the overall trial end date was changed from 31/12/2009 to 28/12/2010.