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    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-003331-32
    Sponsor's Protocol Code Number:AZI003
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-12
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-003331-32
    A.3Full title of the trial
    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
    EEN PROSPECTIEVE, GERANDOMIZEERDE, PLACEBO-GECONTROLEERDE STUDIE MET PRE-TRANSPLANT EN VROEGTIJDIG POST-TRANSPLANT BEHANDELING MET AZITHROMYCINE TER VERBETERING VAN DE INITIELE LONGFUNCTIE EN UITKOMST NA LONGTRANSPLANTATIE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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
    EEN PROSPECTIEVE, GERANDOMIZEERDE, PLACEBO-GECONTROLEERDE STUDIE MET PRE-TRANSPLANT EN VROEGTIJDIG POST-TRANSPLANT BEHANDELING MET AZITHROMYCINE TER VERBETERING VAN DE INITIELE LONGFUNCTIE EN UITKOMST NA LONGTRANSPLANTATIE
    A.4.1Sponsor's protocol code numberAZI003
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKULeuven and University Hospitals Leuven
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKULeuven and University Hospitals Leuven
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportResearch Foundation Flanders (FWO)
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLab of Pneumology, KULeuven
    B.5.2Functional name of contact pointDr. Bart Vanaudenaerde
    B.5.3 Address:
    B.5.3.1Street Address49 Herestraat
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post codeB-3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number+321633 01 94
    B.5.6E-mailbart.vanaudenaerde@med.kuleuven.be
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Azithromycin (Zitromax°)
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameZitromax
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form Syrup
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAZITHROMYCIN
    D.3.9.1CAS number 83905-01-5
    D.3.9.2Current sponsor codeAZI
    D.3.9.3Other descriptive nameAZITHROMYCIN
    D.3.9.4EV Substance CodeSUB05660MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    EARLY LUNG ALLOGRAFT FUNCTION AND OUTCOME
    AFTER LUNG TRANSPLANTATION
    INITIELE LONGFUNCTIE EN UITKOMST NA LONGTRANSPLANTATIE
    E.1.1.1Medical condition in easily understood language
    EARLY LUNG ALLOGRAFT FUNCTION AND OUTCOME
    AFTER LUNG TRANSPLANTATION
    INITIELE LONGFUNCTIE EN UITKOMST NA LONGTRANSPLANTATIE
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10050437
    E.1.2Term Prophylaxis against heart and lung transplant rejection
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10016547
    E.1.2Term FEV
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10050433
    E.1.2Term Prophylaxis against lung transplant rejection
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10006414
    E.1.2Term Bronchial biopsy abnormal
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10025041
    E.1.2Term Lung biopsy abnormal
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10016549
    E.1.2Term FEV 1 abnormal
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10049202
    E.1.2Term Bronchiolitis obliterans
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10025127
    E.1.2Term Lung transplant
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10049237
    E.1.2Term Acute cellular rejection
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10066543
    E.1.2Term Acute allograft rejection
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10039008
    E.1.2Term Reversible airways obstruction NOS
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10019319
    E.1.2Term Heart-lung transplant rejection
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10016550
    E.1.2Term FEV 1 decreased
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10057799
    E.1.2Term Computerised tomogram thorax abnormal
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10063078
    E.1.2Term Bronchoalveolar lavage abnormal
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10056409
    E.1.2Term Heart and lung transplant
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10068956
    E.1.2Term Respiratory tract inflammation
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10049083
    E.1.2Term Respiratory tract infection NOS
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10016553
    E.1.2Term FEV 1 low
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Improvement in mean pulmonary function (FEV1; %pred) during the first 3 months after lung transplantation
    E.2.2Secondary objectives of the trial
    - 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
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    E.4Principal 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
    E.5 End points
    E.5.1Primary end point(s)
    Mean pulmonary function (FEV1; %pred) during the first 3 months after lung transplantation
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after the last subject has been enrolled
    E.5.2Secondary 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
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months after the last subject has been enrolled
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    6 months after the last subject has been enrolled
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Immunocompromised lung transplant recipients
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Final analyses will be performed according to the intention-to-treat principle 6 months after the last subject was enrolled. All patients are in life-long follow-up and outcome variables will be followed up until the patient’s death, independent of the previous continuation or discontinuation of study medication during the scheduled treatment period.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-07
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