Azithromycin in Bronchiolitis Obliterans Syndrome (AZI001)

Catholic University (KU) of Leuven

Status and phase: Completed; Phase 4

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

Treatments: Drug: Placebo; Drug: Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT01009619

AZI001

EudraCT ref. 2005-003893-46 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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83 participants in 2 patient groups, including a placebo group

Azithromycin

Experimental group

Description:

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

Treatment:

Drug: Azithromycin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo