Azithromycin in Bronchiolitis Obliterans Syndrome
Evidence level: registry entry, results posted by sponsor (quoted as posted)
A completed registered phase 4 randomised placebo-controlled trial of azithromycin in lung transplant recipients, sponsored by KU Leuven, with results posted by the sponsor.
As of . Primary source: ClinicalTrials.gov NCT01009619.
Summary
The ClinicalTrials.gov entry, titled "Randomized Double-blind Placebo-controlled Prevention Trial of Azithromycin in Lung Transplantation", lists 83 participants (40 azithromycin and 43 placebo) and a study period from September 2005 to December 2009. The registry posts results. For the primary outcome "Prevalence of Bronchiolitis Obliterans Syndrome (BOS)" at 2 years post-transplant, the registry posts 5 participants in the azithromycin group (n = 40) and 19 in the placebo group (n = 43). For the primary outcome "Overall Survival", the registry posts the values 6 (azithromycin) and 8 (placebo), with the unit given as participants. These numbers are quoted as posted by the sponsor; they have not been independently verified, and no analysis or interpretation is added here. The registry entry was last updated in 2011.
Details
- registry
- ClinicalTrials.gov
- registryId
- NCT01009619
- registryTitle
- Randomized Double-blind Placebo-controlled Prevention Trial of Azithromycin in Lung Transplantation.
- acronym
- AZI001
- sponsor
- KU Leuven
- registryStatus
- completed
- phase
- Phase 4
- studyType
- interventional
- enrolment
- 83 (actual)
- startDate
- 2005-09 (type not stated)
- primaryCompletionDate
- 2009-12 (actual)
- intervention
- Azithromycin (drug); Placebo (drug)
- condition
- Bronchiolitis Obliterans Syndrome; Graft Rejection; Lymphocytic Bronchiolitis; Respiratory Infection
- registryLastUpdatePosted
- 2011-10-03
- registryRead
- 2026-10-10
Sources and links
Related
Links from this record
Known gaps in this record
- results beyond the numbers quoted: not reproduced, no interpretation added
- participating centres and investigators: not recorded
- link to a CLADsolve centre record: not made
Information resource only. Not medical advice. Not a substitute for the care of the patient's transplant team.