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
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
-
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.