Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
83 participants
INTERVENTIONAL
2005-09-30
2009-12-31
Brief Summary
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Detailed Description
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* Clinical setting (tertiary University Hospital).
* Investigator-driven, no pharmaceutical sponsor.
* Lung transplant recipients.
* Add-on of study-drug (placebo or azithromycin) to 'standard of care' (standardized, routine immunosuppressive and infectious prophylactic protocol).
* 1:1 inclusion ratio (placebo:azithromycin).
* Randomisation at discharge after informed consent.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Azithromycin
250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
Azithromycin
Azithromycin 250 mg daily during 5 days followed by 250 mg three times a week on Mon., Wed. and Fri. during study-period.
Placebo
PLacebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
Placebo
Placebo once daily during 5 days, followed by one placebo three times a week on Mon., Wed. and Fri during rest of study-period.
Interventions
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Azithromycin
Azithromycin 250 mg daily during 5 days followed by 250 mg three times a week on Mon., Wed. and Fri. during study-period.
Placebo
Placebo once daily during 5 days, followed by one placebo three times a week on Mon., Wed. and Fri during rest of study-period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
* Adult (age at least 18 years old at moment of transplantation)
* Able to take oral medication
Exclusion Criteria
* Early (\<30 days post-transplant) post-operative death
* Major suture problems (airway stenosis or stent)
* Retransplantation (lung)
* Previous transplantation (solid organ)
* Multi-organ transplantation (lung+ other solid organ)
18 Years
ALL
No
Sponsors
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University Hospital, Gasthuisberg
OTHER
Fund for Scientific Research, Flanders, Belgium
OTHER
KU Leuven
OTHER
Responsible Party
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KULeuven and University Hospital Leuven
Principal Investigators
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Geert M Verleden, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
KULeuven and University Hospitals Leuven
Locations
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Katholieke Universiteit Leuven and University Hospital Gasthuisberg
Leuven, , Belgium
Countries
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References
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Ruttens D, Verleden SE, Vandermeulen E, Bellon H, Vanaudenaerde BM, Somers J, Schoonis A, Schaevers V, Van Raemdonck DE, Neyrinck A, Dupont LJ, Yserbyt J, Verleden GM, Vos R. Prophylactic Azithromycin Therapy After Lung Transplantation: Post hoc Analysis of a Randomized Controlled Trial. Am J Transplant. 2016 Jan;16(1):254-61. doi: 10.1111/ajt.13417. Epub 2015 Aug 4.
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 Jan;37(1):164-72. doi: 10.1183/09031936.00068310. Epub 2010 Jun 18.
Other Identifiers
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EudraCT ref. 2005-003893-46
Identifier Type: REGISTRY
Identifier Source: secondary_id
AZI001
Identifier Type: -
Identifier Source: org_study_id