Condition category
Respiratory
Date applied
05/11/2009
Date assigned
17/12/2009
Last edited
22/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Geert M Verleden

ORCID ID

Contact details

49 Herestraat
Leuven
B-3000
Belgium
+32 (0)16 34 68 08
geert.verleden@uzleuven.be

Additional identifiers

EudraCT number

2005-003893-46

ClinicalTrials.gov number

NCT01009619

Protocol/serial number

AZI001

Study information

Scientific title

Randomised, double-blind, placebo-controlled trial of azithromycin in lung transplantation

Acronym

Study hypothesis

Preventive treatment with azithromycin can reduce the prevalence of bronchiolitis obliterans syndrome after lung transplantation.

Ethics approval

Local Ethical Board (Commissie Medische Ethiek UZ KULeuven), 06/07/2005

Study design

Prospective interventional randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Azithromycin

Primary outcome measures

1. Prevalence of bronchiolitis obliterans syndrome at 1 and 2 year post-transplant
2. Overall survival at 1 and 2 year post-transplant

Secondary outcome measures

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

Overall trial start date

01/09/2005

Overall trial end date

28/12/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant 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)

Recruitment start date

01/09/2005

Recruitment end date

28/12/2010

Locations

Countries of recruitment

Belgium

Trial participating centre

49 Herestraat
Leuven
B-3000
Belgium

Sponsor information

Organisation

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

Sponsor details

c/o Prof Dr GM Verleden
Campus Gasthuisberg
49 Herestraat
Leuven
B-3000
Belgium
+32 (0)16 34 68 08
geert.verleden@uzleuven.be

Sponsor type

Hospital/treatment centre

Website

http://www.uzleuven.be/

Funders

Funder type

Hospital/treatment centre

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

See https://clinicaltrials.gov/ct2/show/results/NCT01009619

Publication summary

2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20562124

Publication citations

  1. Results

    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, 37, 1, 164-172, doi: 10.1183/09031936.00068310.

Additional files

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.