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ISRCTN
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ISRCTN36220396
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ClinicalTrials.gov identifier
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NCT01009619
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Public title
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Azithromycin in bronchiolitis obliterans syndrome
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Scientific title
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Randomised, double-blind, placebo-controlled trial of azithromycin in lung transplantation
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Acronym
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N/A
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Serial number at source
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AZI001
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Study hypothesis
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Preventive treatment with azithromycin can reduce the prevalence of bronchiolitis obliterans syndrome after lung transplantation.
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Lay summary
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Ethics approval
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The Local Ethical Board (Commissie Medische Ethiek UZ KULeuven) approved on the 6th July 2005.
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Study design
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Prospective interventional randomised double-blind placebo-controlled trial
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Countries of recruitment
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Belgium
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Disease/condition/study domain
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Bronchiolitis obliterans syndrome
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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)
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Anticipated start date
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01/09/2005
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Anticipated end date
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28/12/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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80
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Interventions
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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.
As of 10/01/2010 this record was updated to hold the actual end date of the trial; the anticipated end date was 31/12/2009.
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Primary outcome measure(s)
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1. Prevalence of bronchiolitis obliterans syndrome at 1 and 2 year post-transplant
2. Overall survival at 1 and 2 year post-transplant
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Secondary outcome measure(s)
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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
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Sources of funding
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Katholieke Universiteit Leuven and University Hospitals Leuven (Belgium) - Lab of Pneumology, Lung Transplant Unit
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Trial website
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20562124
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Contact name
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Prof
Geert M
Verleden
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Address
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49 Herestraat
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City/town
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Leuven
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Zip/Postcode
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B-3000
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Country
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Belgium
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Tel
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+32 (0)16 34 68 08
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Fax
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+32 (0)16 34 68 03
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Email
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geert.verleden@uzleuven.be
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Sponsor
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Katholieke Universiteit Leuven and University Hospitals Leuven (Belgium) - Lab of Pneumology, Lung Transplant Unit
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Address
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c/o Prof Dr GM Verleden
Campus Gasthuisberg
49 Herestraat
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City/town
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Leuven
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Zip/Postcode
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B-3000
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Country
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Belgium
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Tel
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+32 (0)16 34 68 08
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Fax
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+32 (0)16 34 68 03
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Email
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geert.verleden@uzleuven.be
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Sponsor website:
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http://www.uzleuven.be/
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Date applied
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05/11/2009
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Last edited
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10/01/2011
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Date ISRCTN assigned
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17/12/2009
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