Azithromycin in bronchiolitis obliterans syndrome
| ISRCTN | ISRCTN36220396 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36220396 |
| EudraCT/CTIS number | 2005-003893-46 |
| ClinicalTrials.gov number | NCT01009619 |
| Secondary identifying numbers | AZI001 |
- Submission date
- 05/11/2009
- Registration date
- 17/12/2009
- Last edited
- 22/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Geert M Verleden
Scientific
Scientific
49 Herestraat
Leuven
B-3000
Belgium
| Phone | +32 (0)16 34 68 08 |
|---|---|
| geert.verleden@uzleuven.be |
Study information
| Study design | Prospective interventional randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised, double-blind, placebo-controlled trial of azithromycin in lung transplantation |
| Study objectives | Preventive treatment with azithromycin can reduce the prevalence of bronchiolitis obliterans syndrome after lung transplantation. |
| Ethics approval(s) | Local Ethical Board (Commissie Medische Ethiek UZ KULeuven), 06/07/2005 |
| Health condition(s) or problem(s) studied | Bronchiolitis obliterans syndrome |
| Intervention | Add-on of study-drug (over-encapsulated placebo or azithromycin) to 'standard of care'. Study-drug regime: 250 mg daily for 5 days, followed by 250 mg every other day until the end of the study-period. Matching placebo regimen. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Azithromycin |
| Primary outcome measure | 1. Prevalence of bronchiolitis obliterans syndrome at 1 and 2 year post-transplant 2. Overall survival at 1 and 2 year post-transplant |
| Secondary outcome measures | 1. Acute rejection rate at 1 and 2 year post-transplant 2. Infection rate at 1 and 2 year post-transplant 3. Evolution of pulmonary function during the first and second year after transplantation 4. Evolution of bronchoalveolar lavage (BAL) cellularity, protein levels and microbiology during the first and second year after transplantation |
| Overall study start date | 01/09/2005 |
| Completion date | 28/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | 1. Stable LTx recipients at discharge after transplantation 2. Signed informed consent 3. Adult of either sex (aged at least 18 years old at moment of transplantation) 4. Able to take oral medication |
| Key exclusion criteria | 1. Prolonged and/or complicated intensive care unit (ICU) course after lung transplantation 2. Early (less than 30 days post-transplant) post-operative death 3. Major suture problems (airway stenosis or stent) 4. Retransplantation (lung) 5. Previous transplantation (solid organ) 6. Multi-organ transplantation (lung and other solid organ) |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 28/12/2010 |
Locations
Countries of recruitment
- Belgium
Study participating centre
49 Herestraat
Leuven
B-3000
Belgium
B-3000
Belgium
Sponsor information
Katholieke Universiteit Leuven and University Hospitals Leuven (Belgium) - Lab of Pneumology, Lung Transplant Unit
Hospital/treatment centre
Hospital/treatment centre
c/o Prof Dr GM Verleden
Campus Gasthuisberg
49 Herestraat
Leuven
B-3000
Belgium
| Phone | +32 (0)16 34 68 08 |
|---|---|
| geert.verleden@uzleuven.be | |
| Website | http://www.uzleuven.be/ |
"ROR" |
https://ror.org/05f950310 |
Funders
Funder type
Hospital/treatment centre
Katholieke Universiteit Leuven and University Hospitals Leuven (Belgium) - Lab of Pneumology, Lung Transplant Unit
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | results | 01/01/2011 | Yes | No |
Editorial Notes
22/03/2016: added link to results - basic reporting.
On 10/01/2010 the overall trial end date was changed from 31/12/2009 to 28/12/2010.
