AzTrials
AzTrials

Bronchiolitis Obliterans SyndromePhase 4AZI001NCT01009619

Azithromycin in Bronchiolitis Obliterans Syndrome

A Phase 4 study testing Azithromycin in people with Bronchiolitis Obliterans Syndrome and Graft Rejection, run by KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Preventive treatment with azithromycin reduces the prevalence fo Bronchiolitis Obliterans Syndrome after lung transplantation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Azithromycin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
83 participants
Where
1 siteBelgium
Study dates
Sep 2005to Dec 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Katholieke Universiteit Leuven and University Hospital Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

About this study

Official title: Randomized Double-blind Placebo-controlled Prevention Trial of Azithromycin in Lung Transplantation.

Preventive treatment with azithromycin reduces the prevalence fo Bronchiolitis Obliterans Syndrome after lung transplantation.

Read the detailed description
  • Prospective, interventional, randomized, double-blind, placebo-controlled trial.
  • Clinical setting (tertiary University Hospital).
  • Investigator-driven, no pharmaceutical sponsor.
  • Lung transplant recipients.
  • Add-on of study-drug (placebo or azithromycin) to 'standard of care' (standardized, routine immunosuppressive and infectious prophylactic protocol).
  • 1:1 inclusion ratio (placebo:azithromycin).
  • Randomisation at discharge after informed consent.
Being tested
Azithromycin, Placebo
Keywords
Bronchiolitis Obliterans Syndrome, Acute allograft Rejection, Lymphocytic bronchiolitis, Respiratory infection, Survival, Mortality, Pulmonary function, FEV1, Broncho-alveolar lavage, Neutrophils, Interleukin, Culture, Azithromycin
Medical subject headings
Bronchiolitis Obliterans Syndrome, Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AzithromycinDrug

    Also called Zitromax (Azithromycin Dihydrate, Pfizer, ZTM250)

    Azithromycin 250 mg daily during 5 days followed by 250 mg three times a week on Mon., Wed. and Fri. during study-period.

  • PlaceboDrug

    Also called Lactose monohydricum Ph.Eur. (Fagron)

    Placebo once daily during 5 days, followed by one placebo three times a week on Mon., Wed. and Fri during rest of study-period.

Study groups in NCT01009619
Study groupRoleWhat they receive
AzithromycinExperimental250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
Receives: Drug: Azithromycin
PlaceboPlacebo comparatorPLacebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of Bronchiolitis Obliterans Syndrome (BOS)

    BOS was defined as a sustained decrease in forced Expiratory Volume in one second (FEV1) of at least 20% from the patient's maximum post-operative values in the absence of other causes.

    Measured: 2 years post-transplant

  2. Overall Survival

    Survival data were obtained using all-cause mortality information in the Leuven University Hospital transplant database, in which all our lung transplant recipients since 1991 are registered. For the end-point of all-cause mortality, survival times were not censored at retransplantation or at study-discontinuation if these preceded death, or else at 2 years after transplantation.

    Measured: 2 years post-transplant

Secondary outcomes (5)

  1. Acute Rejection Incidence Rate

    Bronchoscopy and broncho-alveolar lavage (BAL) was routinely performed at discharge, 3, 6, 12, 18, 24 months post-transplantation and later at intervals of 1 year, or in case of clinically suspected acute allograft rejection, infection or chronic rejection. Transbronchial biopsies were routinely performed at discharge and 3 months post-transplant or in case of suspected acute rejection, infection or chronic rejection. Biopsies were graded according to the 1996 ISHLT-guidelines (grade A0-4 with concomitant B0-4), as well as assessed for other interstitial lesions of the pulmonary graft.

    Measured: 2 years post-transplant

  2. Infection Incidence Rate

    Cytomegalovirus (CMV)-status was assessed on on every broncho-alevolar lavage sample and by serum CMV DNA at weekly intervals during hospitalization and thereafter at each outpatient evaluation or hospital admission. Immunohistochemical staining for CMV was performed on transbronchial biopsies in case of clinical suspicion of infection (i.e. dyspnea, cough, sputum, fever, increased plasma C-reactive protein, new chest radiograph infiltrates, or a decrease of at least 10% in peak expiratory flow (PEF) as measured by patient's peak flow measurements.

    Measured: 2 years post-transplant

  3. Pulmonary Function

    Spirometry (Masterscreen, Jaeger, Hoechberg, Germany) was performed at twice weekly intervals for the first 2 postoperative months, thereafter at weekly to biweekly intervals until 6 months post-transplantation, then every 2 to 4 weeks until the first postoperative year and afterwards life-long at intervals of 2 to 3 months according to American Thoracic Society standards and forced expiratory volume in one second (FEV1) expressed in terms of the percentage of predicted values.

    Measured: during first two years post-transplant

  4. Broncho-alveolar (BAL) Neutrophilia

    BAL was performed with two 50 mL aliquots of sterile saline at room temperature. Five mL of the recovered BAL fluid was sent for microbiological and virological assessment, whereas the remaining fluid was analysed for cell counts after a cytospin was made in a Shandon cytocentrifuge and stained with May-Grünwald-Giemsa. Differential cell counts were determined by counting at least 300 cells.

    Measured: during first two years post-transplant

  5. Plasma C-reactive Protein (CRP) Levels

    Plasma C-reactive protein (CRP) levels were assessed using Tina-quant CRP latex assay, Roche, Mannheim, Germany; sensitivity threshold of 1 mg/L, upper limit of normal 5 mg/L.

    Measured: during the first two years post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2009 (estimated)
  2. Study startSep 2005
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01009619
Sponsor's protocol ID
AZI001
Other IDs
EudraCT ref. 2005-003893-46
Acronym
AZI001
Status last verified
Aug 2011
First submitted
6 Nov 2009
Last updated
3 Oct 2011
Data monitoring committee
No

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.

    PubMed 26372728

  • 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.

    PubMed 20562124

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Azithromycin in people with Bronchiolitis Obliterans Syndrome and Graft Rejection, run by KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of Bronchiolitis Obliterans Syndrome (BOS) (time frame: 2 years post-transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01009619, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2011; AzTrials last refreshed its copy on 31 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in