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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003331-32-BE

Enrollment

Registered

2012-11-12

Start date

2013-06-18

Completion date

Unknown

Last updated

2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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 Or

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Improvement in 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;Primary end point(s): Mean pulmonary function (FEV1; %pred) during the first 3 months after lung transplantation ;Timepoint(s) of evaluation of this end point: 6 months after the last subject has been enrolled	—

Measure

Time frame

Main Objective: Improvement in 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;Primary end point(s): Mean pulmonary function (FEV1; %pred) during the first 3 months after lung transplantation ;Timepoint(s) of evaluation of this end point: 6 months after the last subject has been enrolled

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Belgium

Contacts

Public ContactDr. Bart Vanaudenaerde

Lab of Pneumology, KULeuven

bart.vanaudenaerde@med.kuleuven.be+321633 01 94

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026