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    Summary
    EudraCT Number:2018-001109-99
    Sponsor's Protocol Code Number:SPON1595-17
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-05-30
    Trial 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 ConcernedUK - MHRA
    A.2EudraCT number2018-001109-99
    A.3Full title of the trial
    A randomised, placebo controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AZTEC: Azithromycin Therapy for Chronic Lung Disease of Prematurity
    A.3.2Name or abbreviated title of the trial where available
    Azithromycin Therapy for Chronic Lung Disease of Prematurity
    A.4.1Sponsor's protocol code numberSPON1595-17
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN11650227
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCardiff University
    B.1.3.4CountryUnited Kingdom
    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 supportNational Institute for Health Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCardiff University
    B.5.2Functional name of contact pointResearch Governance Team
    B.5.3 Address:
    B.5.3.1Street Address30-36 Newport Road
    B.5.3.2Town/ cityCardiff
    B.5.3.3Post codeCF240DE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02920879131
    B.5.6E-mailresgov@cardiff.ac.uk
    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
    D.2.1.1.2Name of the Marketing Authorisation holderAspire Pharma Limited
    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 nameAzithromycin
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNazithromycin
    D.3.9.1CAS number 121479-24-4
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bronchopulomary dysplasia
    E.1.1.1Medical condition in easily understood language
    Chronic Lung disease of Prematurity
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066204
    E.1.2Term Chronic lung disease of prematurity
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006475
    E.1.2Term Bronchopulmonary dysplasia
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effectiveness of azithromycin in increasing survival without physiologically defined CLD (moderate/severe) when compared to placebo
    E.2.2Secondary objectives of the trial
    1) To determine the effect of azithromycin on mortality rate (at 36 weeks’ postmenstrual age)
    2) To determine the effectiveness of azithromycin in reducing duration of respiratory support
    3) To determine the safety and tolerability of azithromycin
    4) To determine if azithromycin alters resistance to macrolides amongst Streptococcus and Staphylococcus spp microbes isolated from respiratory and stool samples
    In Ureaplasma positive infants only
    5) To investigate if colonisation with Ureaplasma spp. prior to randomisation modifies the treatment effect of azithromycin compared to placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Gestational age ≤29w+6d (including infants born as one of a multiple birth)
    b) Neonates who have had respiratory support for at least 2 continuous hours duration during the first 72 hours of life (intubated, or by non-invasive mechanical ventilation including continuous positive airway pressure and high flow nasal cannula or a combination thereof)
    c) Presence of an indwelling intravenous line for drug administration
    d) Written informed consent within 72 hours of birth at the latest
    e) Anticipating administration of first dose within 72 hours of birth at the latest
    f) Reasonable to expect completion of 10 days of trial treatment whilst resident at the recruiting site
    g) Inborn, or born at site within the recruiting site's neonatal network where follow up will be possible
    h) In the opinion of the PI, reasonable prospect of survival past the first 72 hours of life
    E.4Principal exclusion criteria
    a) Exposure to another systemic macrolide antibiotic (not maternal)
    b) Presence of major surgical or congenital abnormalities (not including patent ductus arteriosus or patent foramen ovale)
    c) Known contraindication of azithromycin as specified in the summary of characteristics of the product
    d) Participation in other interventional trials that precludes participation in AZTEC
    E.5 End points
    E.5.1Primary end point(s)
    1) Death
    2) Physiologically defined CLD at 36 weeks’ postmenstrual age
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 weeks postmenstrual age
    E.5.2Secondary end point(s)
    A) Death

    B) Number of days of respiratory support required:
    1) conventional mechanical ventilation/HFOV
    2) continuous positive airway pressure
    3) high flow nasal cannula
    4) number of days of oxygen dependency

    C) Development of Complications of Prematurity
    1) Nosocomial infection (line- sepsis, meningitis, pneumonia); confirmed microbiologically or antibiotic treatment for 5 days or more
    2) severe intraventricular haemorrhage (grade III/IV)
    3) necrotising enterocolitis (Bell stage II and above)
    4) treatment for retinopathy of prematurity
    5) treatment for patent ductus arteriosus
    6) Serious adverse events/reactions
    Following any unexpected and unexplained arrhythmias on routine heart rate monitoring, formal ECG will be obtained to assess QTc interval with follow up ECG 10 days after stopping treatment.

    D) Resistance to macrolides among microbes isolated from respiratory and stool samples
    E.5.2.1Timepoint(s) of evaluation of this end point
    A) 36 weeks postmenstrual age
    B) Discharge from hospital
    C) Until 36 weeks’ postmenstrual age, or discharge home from hospital (whichever is soonest
    D) Up to 21 days of life
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned30
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA30
    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 Yes
    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
    Database lock
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 796
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 796
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 Yes
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Preterm infants
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state796
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 796
    F.4.2.2In the whole clinical trial 796
    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)
    Standard care as warranted by national and local neonatal practice
    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 Decision2018-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-29
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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