ISRCTN ISRCTN36220396
DOI https://doi.org/10.1186/ISRCTN36220396
EudraCT/CTIS number 2005-003893-46
ClinicalTrials.gov number NCT01009619
Secondary identifying numbers AZI001
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

Study designProspective interventional randomised double-blind placebo-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRandomised, double-blind, placebo-controlled trial of azithromycin in lung transplantation
Study objectivesPreventive 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) studiedBronchiolitis obliterans syndrome
InterventionAdd-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 typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Azithromycin
Primary outcome measure1. Prevalence of bronchiolitis obliterans syndrome at 1 and 2 year post-transplant
2. Overall survival at 1 and 2 year post-transplant
Secondary outcome measures1. 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
Overall study start date01/09/2005
Completion date28/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants80
Key inclusion criteria1. 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 criteria1. 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 enrolment01/09/2005
Date of final enrolment28/12/2010

Locations

Countries of recruitment

  • Belgium

Study participating centre

49 Herestraat
Leuven
B-3000
Belgium

Sponsor information

Katholieke Universiteit Leuven and University Hospitals Leuven (Belgium) - Lab of Pneumology, Lung Transplant Unit
Hospital/treatment centre

c/o Prof Dr GM Verleden
Campus Gasthuisberg
49 Herestraat
Leuven
B-3000
Belgium

Phone +32 (0)16 34 68 08
Email geert.verleden@uzleuven.be
Website http://www.uzleuven.be/
ROR logo "ROR" https://ror.org/05f950310

Funders

Funder type

Hospital/treatment centre

Katholieke Universiteit Leuven and University Hospitals Leuven (Belgium) - Lab of Pneumology, Lung Transplant Unit

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

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.