drugset / Trial / NCT01009619
Azithromycin in Bronchiolitis Obliterans Syndrome
Phase 4
Completed
83 enrolled
KU Leuven
Fund for Scientific Research, Flanders, Belgium · collabUniversity Hospital, Gasthuisberg · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Preventive treatment with azithromycin reduces the prevalence fo Bronchiolitis Obliterans Syndrome after lung transplantation.
Timeline
- Start
- 2005-09
- Primary completion
- 2009-12
- Completion
- 2009-12
Outcome
Mixed primary results
paper Primary end-points were BOS-free and overall survival 2 yrs after LTx PMID 20562124 ↗
paper BOS occurred less in patients receiving azithromycin: 12.5 versus 44.2% (p = 0.0017). PMID 20562124 ↗
paper Overall survival, acute rejection, lymphocytic bronchiolitis, pneumonitis, colonisation and reflux were comparable between groups. PMID 20562124 ↗
Publications
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azithromycin | Small molecule | 250 mg | — |