A PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRE-TRANSPLANT AND PROMPT POST-TRANSPLANT TREATMENT WITH AZITHROMYCIN TO IMPROVE EARLY ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION

• Register: EUCTR
• Last refreshed on: 11 June 2018
• Main ID: EUCTR2012-003331-32-BE
• Date of registration: 12/11/2012
• Prospective Registration: Yes
• Primary sponsor: KULeuven and University Hospitals Leuven
• Public title: A PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRE-TRANSPLANT AND PROMPT POST-TRANSPLANT TREATMENT WITH AZITHROMYCIN TO IMPROVE EARLY ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION
• Scientific title: A PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRE-TRANSPLANT AND PROMPT POST-TRANSPLANT TREATMENT WITH AZITHROMYCIN TO IMPROVE EARLY ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION
• Date of first enrolment: 18/06/2013
• Target sample size: 60
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003331-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Belgium

Contacts

• Name: Dr. Bart Vanaudenaerde
• Affiliation: Lab of Pneumology, KULeuven

• Name: Dr. Bart Vanaudenaerde
• Affiliation: Lab of Pneumology, KULeuven

Key inclusion & exclusion criteria

Inclusion criteria:
- Signed informed consent
- Adult (age at least 18 years old at moment of transplantation)
- Single lung transplantation, sequential single (double) lung transplantation or heart-lung transplantation

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Known previous allergy for azithromycin (including skin reactions such as rash, urticaria or Stevens-Johnson syndrome, angioneurotic oedema and anaphylaxis)
- Retransplantation or multi-organ (other than heart-lung) transplantation



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

EARLY LUNG ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION
MedDRA version: 14.1 Level: LLT Classification code 10050437 Term: Prophylaxis against heart and lung transplant rejection System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1 Level: LLT Classification code 10016547 Term: FEV System Organ Class: 10022891 - Investigations
MedDRA version: 14.1 Level: LLT Classification code 10050433 Term: Prophylaxis against lung transplant rejection System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1 Level: LLT Classification code 10006414 Term: Bronchial biopsy abnormal System Organ Class: 10022891 - Investigations
MedDRA version: 14.1 Level: LLT Classification code 10025041 Term: Lung biopsy abnormal System Organ Class: 10022891 - Investigations
MedDRA version: 14.1 Level: LLT Classification code 10016549 Term: FEV 1 abnormal System Organ Class: 10022891 - Investigations
MedDRA version: 14.1 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1 Level: PT Classification code 10025127 Term: Lung transplant System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1 Level: LLT Classification code 10049237 Term: Acute cellular rejection System Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.1 Level: LLT Classification code 10066543 Term: Acute allograft rejection System Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.1 Level: LLT Classification code 10039008 Term: Reversible airways obstruction NOS System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1 Level: PT Classification code 10019319 Term: Heart-lung transplant rejection System Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.1 Level: LLT Classi

Intervention(s)

Trade Name: Azithromycin (Zitromax°)
Product Name: Zitromax
Product Code: not applicable
Pharmaceutical Form: Syrup
INN or Proposed INN: AZITHROMYCIN
CAS Number: 83905-01-5
Current Sponsor code: AZI
Other descriptive name: AZITHROMYCIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: Improvement in mean pulmonary function (FEV1; %pred) during the first 3 months after lung transplantation

Primary end point(s): Mean pulmonary function (FEV1; %pred) during the first 3 months after lung transplantation

Secondary Objective: - Length of intubation
- Length of ICU stay
- Length of hospital stay
- PaO2/FiO2 at 24, 48 and 72 hours after lung transplantation
- Primary graft dysfunction (PGD) prevalence and score at 24, 48 and 72 hours after lung
transplantation
- 6-minute walking distance at discharge after lung transplantation
- Acute rejection (grade A; grade B) prevalence/severity at discharge, 3 and 6 months after lung
transplantation
- Broncho-alveolar lavage neutrophilia and cytokine/protein levels (e.g. IL-8 and IL-6) at day 1,
discharge, 1, 3 and 6 months after lung transplantation
- Airway colonization at discharge, 1, 3 and 6 months after lung transplantation
- Plasma C-reactive protein levels at day 1, 7, discharge, 1, 3 and 6 months after lung transplantation
- Mortality at 1, 3 and 6 months after lung transplantation

Timepoint(s) of evaluation of this end point: 6 months after the last subject has been enrolled

Secondary Outcome(s)

Secondary end point(s): - Length of intubation
- Length of ICU stay
- Length of hospital stay
- PaO2/FiO2 at 24, 48 and 72 hours after lung transplantation
- Primary graft dysfunction (PGD) prevalence and score at 24, 48 and 72 hours after lung
transplantation
- 6-minute walking distance at discharge after lung transplantation
- Acute rejection (grade A; grade B) prevalence/severity at discharge, 3 and 6 months after lung
transplantation
- Broncho-alveolar lavage neutrophilia and cytokine/protein levels (e.g. IL-8 and IL-6) at day 1,
discharge, 1, 3 and 6 months after lung transplantation
- Airway colonization at discharge, 1, 3 and 6 months after lung transplantation
- Plasma C-reactive protein levels at day 1, 7, discharge, 1, 3 and 6 months after lung transplantation
- Mortality at 1, 3 and 6 months after lung transplantation

Timepoint(s) of evaluation of this end point: 6 months after the last subject has been enrolled

Secondary ID(s)

AZI003

Source(s) of Monetary Support

KULeuven and University Hospitals Leuven

Research Foundation Flanders (FWO)