NCT00563251: Azithromycin after stem-cell-transplant lung injury

Medicine Signal Editorial Desk
Updated 2026-10-10

Registry status when checked 2026-10-10Completed

NCT00563251 tested azithromycin for established bronchiolitis obliterans syndrome after hematopoietic stem-cell transplantation. This is treatment of an existing complication, not preventive antibiotic treatment in all transplant recipients. 1 2 3

The randomized, double-blind publication compared 10 participants receiving azithromycin 250 mg daily with 12 receiving placebo for 12 weeks. Lung-function testing and the St George’s Respiratory Questionnaire were used to assess response. The report did not find a significant treatment advantage. The published analysis population of 22 should not be replaced by the registry’s larger enrollment figure. 1 2 3

The small sample limits precision. The result does not establish that azithromycin benefits this condition and must not be merged with trials involving lung-transplant recipients or prophylaxis before bronchiolitis develops. 3

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00563251. Original study registration: sponsor, design, population, endpoints and dated history.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00563251. Original study registration: sponsor, design, population, endpoints and dated history.

2. ICH GCP — ICH GCP — readable reproduction of the sponsor-submitted ClinicalTrials.gov record. Supports the registration details quoted here; not an independent clinical-results publication.Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.

3. PubMed — Original randomized study: Lam et al., 2011Research publication · Publication abstract read via Europe PMC; identifier and title cross-checked. Checked 2026-10-10. Full paper was not independently re-read for this update; abstract details should not be extended beyond what it reports.