Phase 4
N=83
Azithromycin in Bronchiolitis Obliterans Syndrome
Bronchiolitis Obliterans Syndrome · Graft Rejection · Lymphocytic Bronchiolitis · Respiratory Infection
Bottom Line
View on ClinicalTrials.gov: NCT01009619 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Prevalence of Bronchiolitis Obliterans Syndrome (BOS) — 5; 19 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Azithromycin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- KU Leuven
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevalence of Bronchiolitis Obliterans Syndrome (BOS) |
5; 19 | — |
| PRIMARY Overall Survival |
6; 8 | — |
| SECONDARY Acute Rejection Incidence Rate |
0.86; 0.78 | <0.05 sig |
| SECONDARY Infection Incidence Rate |
0.95; 0.73 | <0.05 sig |
| SECONDARY Pulmonary Function |
81.11; 75.28 | — |
| SECONDARY Broncho-alveolar (BAL) Neutrophilia |
9.68; 15.73 | — |
| SECONDARY Plasma C-reactive Protein (CRP) Levels |
7.06; 10.02 | — |
Summary
Preventive treatment with azithromycin reduces the prevalence fo Bronchiolitis Obliterans Syndrome after lung transplantation.
Eligibility Criteria
Inclusion Criteria
- Stable LTx recipients at discharge after transplantation.
- Signed informed consent
- Adult (age at least 18 years old at moment of transplantation)
- Able to take oral medication
Exclusion Criteria
- Prolonged and/or complicated ICU-course after transplantation.
- 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)
Data sourced from ClinicalTrials.gov (NCT01009619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.