Azithromycin in Bronchiolitis Obliterans Syndrome

NCT01009619 | Completed Phase 4 Results

• 2 other identifiers: AZI001EudraCT ref. 2005-003893-46
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bronchiolitis Obliterans Syndrome; Graft Rejection; Lymphocytic Bronchiolitis; Respiratory Infection

Keywords

Bronchiolitis Obliterans Syndrome; Acute allograft Rejection; Lymphocytic bronchiolitis; Respiratory infection; Survival; Mortality; Pulmonary function; FEV1; Broncho-alveolar lavage; Neutrophils; Interleukin; Culture; Azithromycin

Outcome Measures

Primary Outcomes (2)

• 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.

  2 years post-transplant

• 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.

  2 years post-transplant

Secondary Outcomes (5)

• Acute Rejection Incidence Rate

  2 years post-transplant

• Infection Incidence Rate

  2 years post-transplant

• Pulmonary Function

  during first two years post-transplant

• Broncho-alveolar (BAL) Neutrophilia

  during first two years post-transplant

• Plasma C-reactive Protein (CRP) Levels

  during the first two years post-transplant

Study Arms (2)

Azithromycin

EXPERIMENTAL

250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study

Drug: Azithromycin

Placebo

PLACEBO COMPARATOR

PLacebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.

Drug: Placebo

Interventions

Azithromycin DRUG

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

Also known as: Zitromax (Azithromycin Dihydrate, Pfizer, ZTM250)

Azithromycin

Placebo DRUG

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

Also known as: Lactose monohydricum Ph.Eur. (Fagron)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• KU Leuven: lead
• University Hospital, Gasthuisberg: collaborator
• Fund for Scientific Research, Flanders, Belgium: collaborator

Study Sites (1)

Katholieke Universiteit Leuven and University Hospital Gasthuisberg

Leuven, B-3000, Belgium

Location

Related Publications (2)

• 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.

  PMID: 26372728 DERIVED

• 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.

  PMID: 20562124 DERIVED

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome; Respiratory Tract Infections

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Infections

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Prof. Dr. GM Verleden
• Organization: Katholieke Universiteit Leuven and University Hospital Leuven

geert.verleden@uzleuven.be

+32 16 34 68 08

Study Officials

• Geert M Verleden, Prof. Dr.

  KULeuven and University Hospitals Leuven

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 6, 2009
• First Posted: November 9, 2009
• Study Start: September 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 3, 2011
• Results First Posted: August 25, 2011

Record last verified: 2011-08

Locations

BE (1)