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    The EU Clinical Trials Register currently displays   41200   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-003889-14
    Sponsor's Protocol Code Number:C12-75
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-12-11
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2013-003889-14
    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
    Az azithromycin randomizált, placebo kontrollált vizsgálata krónikus tüdőbetegség megelőzésére, koraszülött gyermekeknél
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treat Infections in Neonates 2
    Fertőzések kezelése újszülötteknél 2
    A.3.2Name or abbreviated title of the trial where available
    TINN2
    A.4.1Sponsor's protocol code numberC12-75
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/037/2013
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInstitut National de la Santé et de la Research Médicale
    B.1.3.4CountryFrance
    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 supportEuropean Commission 7th Framework Programme
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInserm
    B.5.2Functional name of contact pointSonia GUEGUEN
    B.5.3 Address:
    B.5.3.1Street Address8 rue de la Croix jarry
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75013
    B.5.3.4CountryFrance
    B.5.4Telephone number33144236047
    B.5.5Fax number33144236710
    B.5.6E-mailrqrc.siege@inserm.fr
    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 holderDr. Friedrich Eberth Arzneimittel GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.11 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 injection/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
    Bronchopulmonary Dysplasia
    Bronchopulmonális dysplazia
    E.1.1.1Medical condition in easily understood language
    Chronic Lung Disease of Prematurity
    Koraszülöttek krónikus tüdőbetegsége
    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 17.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy azithromycin on the rate of survival without CLD in preterm infants of ≤28 weeks (28+6) gestation
    Az azithromycin hatásának vizsgálata legfeljebb a 28. terhességi héten (28. hét +6 nap) született koraszülöttek CLD-mentes túlélési arányára
    E.2.2Secondary objectives of the trial
    Mortality rate at 28 days of life, 36 weeks PMA, 2 years of life ; Severity of CLD according to NIH definition; Pulmonary colonisation by Ureaplasma spp.; Duration of positive pressure respiratory support; Inflammatory markers in bronchoalveolar lavage; Microbiological markers including Ureaplasma spp, Mycoplasma spp; Resistance to azithromycin in Ureaplasma; Resistance to azithromycin among microbes isolated from stool or rectal swab; Exposure to supplemental antibiotics; Development of complications of prematurity; Safety and tolerability assessment; Pharmacokinetics; Respiratory, neurological and cognitive development the corrected age of 24 months
    Mortalitási arány a 28. napon, 36. heti postmenstruációs időben, 2 éves korban;
    A CLD súlyossága a NIH szerint; az Ureaplazma fajok pulmonális kolonizációja; a pozitív nyomású lélegeztetés időtartama; gyulladási markerek a bronchoalveolaris lavázsban; mikrobiológiai markerek, beleértve az Ureaplazma és Mycoplazma fajokat; az Ureplazma fajok azithromycin rezisztenciája; a székletből vagy végbélkaparékból izolált mikrobák azithromycin rezisztenciája; kiegészítő antibiotikumos kezelés; a koraszületés komplikációi; biztonságossági és tolerálhatósági értékelések; farmakokinetika; légzőszervi és neurológiai kimenetelek 24 hónapos korrigált életkorban
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PK study as included in the main trial protocol: This sub-study will be conducted in selected centres only to include 100 infants.
    The objective of the PK study is to validate the simulation used to identify the appropriate dose of azithromycin to eradicate Ureaplasma.

    Inflammatory markers study as included in the main protocol: This sub-study will be conducted in selected centres only to include 200 infants.
    The objective it so assess the difference in levels of cytokines in lung fluid between the azithromycin and placebo. Cytokines (such as IL6 and IL8) are 'biomarkers' of inflammation and a reduction of these in the treatment group will point towards the efficacy of azithromycin as an anti-inflammatory.
    Hungarian sites are not selected for inflammatory markers study.

    Pharmacogenetic sub-study as included in the main protocol: The objective of the genetic sub-study are 1) to assess the impact of genetic factors on the distribution of azithromycin inside white blood cells important for instigating an immune response (macrophages); 2) to explore the genetic influence on predisposition to infections.

    A vizsgálati terv tartalmaz farmakokinetikai vizsgálatokat is: ez egy alvizsgálat, amely csak a kiválasztott centrumokban történik, 100 gyermek részvételével. A farmakokinetikai vizsgálat célja annak a szimulációnak az értékelése amely az Ureaplazma felszámolásához szükséges azithromycin megfelelő dózisának kiválasztásakor alkalmaztak.

    A gyulladási markerek vizsgálat része a vizsgálati tervnek: ez egy alvizsgálat, amely csak a kiválasztott centrumokban történik, 200 gyermek részvételével. A célja a tüdőfolyadékban lévő citokinek szintjének vizsgálata az azithromycin és placebó között. A citokinek (mint pl. az IL6 és IL8) gyulladást jelzik ezért ezek csökkenése a kezelési csoportban az azithromycin gyulladáscsökkentő hatását fogja mutatni.
    A magyarországi vizsgálóhelyek nem vesznek részt a gyulladási markerek vizsgálatban.

    A farmakogenetikai alvizsgálat része a vizsgálati tervnek: a célja ennek a genetikai alvizsgálatnak, hogy 1) megvizsgálja a genetikai tényezők hatását az azithromycin fehérvérsejtekben történő eloszlásában az immunválasz elérésekor (makrofágok); 2) a fertőzések genetikai hajlamosító tényezőinek feltárása.
    E.3Principal inclusion criteria
    a) Pre-term, ≤28 weeks gestational age (i.e. 28 weeks and 6 days, including infants born as one of a multiple birth)
    b) Requirement for respiratory support within 12hrs of birth (intubated, or by non-invasive mechanical ventilation inc. continuous positive airway pressure)
    c) Presence of an indwelling intravenous line for drug administration
    d) Inborn, or born at site within the recruiting centre’s neonatal network where follow up will be possible
    a) Koraszületés, legfeljebb a 28. terhességi hét (azaz legfeljebb 28. hét +6 nap beleértve ikerszületés esetén bármelyik gyermeket).
    b) A születést követően 12 órán belül szükséges légzéstámogatás (intubált, vagy nem-invazív mechanikus lélegeztetés beleértve a folyamatos pozitív nyomású lélegeztetést).
    c) Behelyezett intravénás kanül gyógyszer adagolásához.
    d) A vizsgálóhely újszülött ellátási hálózatában, a vizsgálóhelyen, vagy a vizsgálóhelyen kívül született csecsemő, ahol az utánkövetés lehetséges.
    E.4Principal exclusion criteria
    a) In the opinion of the PI, babies unlikely to survive until 48 hours after birth
    b) Exposure to another macrolide antibiotic
    c) Presence of major surgical or congenital abnormalities (not including patent ductus arteriosus or patent foramen ovale)
    d) Infants born as part of a multiple pregnancy of three or more (i.e. triplets or more)
    e) Participation in other clinical trials involving IMPs
    a) A vizsgálatvezető véleménye szerint a baba nem él 48 óránál tovább a születése után.
    b) Egyéb makrolid antibiotikum alkalmazása.
    c) Jelentős sebészeti beavatkozás szükségessége vagy születési rendellenesség jelenléte (ide nem értve a nyitott ductus arteriosust vagy a nyitott foramen ovale-t).
    d) Olyan csecsemő, aki hármas, vagy annál többszörös iker tagja.
    e) Egy másik, vizsgálati készítmény alkalmazásával történő klinikai vizsgálatban való részvétel.
    E.5 End points
    E.5.1Primary end point(s)
    Chronic Lung disease or Death
    Krónikus tüdőbetegség vagy halál
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 weeks postmenstrual age
    36. postmenstruációs hét
    E.5.2Secondary end point(s)
    1. Mortality
    2. Severity of CLD according to NIH definition
    3. Pulmonary colonisation by Ureaplasma spp.
    4. Duration of positive pressure respiratory support
    5. Inflammatory markers in bronchoalveolar lavage
    6. Resistance to azithromycin in Ureaplasma
    7. Resistance to azithromycin among microbes isolated from stool or rectal swab
    8. Exposure to supplementary antibiotics
    9. Development of complications of prematurity
    10. Safety and tolerability
    11. Pharmacokinetics
    12. Respiratory, neurological and cognitive measurements
    1. Mortalitás
    2. A CLD súlyossága a NIH szerint
    3. Az Ureaplazma fajok pulmonális kolonizációja
    4. A pozitív nyomású lélegeztetés időtartama
    5. Gyulladási markerek a bronchoalveolaris lavázsban
    6. Az Ureplazma fajok azithromycin rezisztenciája
    7. A székletből vagy végbélkaparékból izolált mikrobák azithromycin rezisztenciája
    8. Kiegészítő antibiotikumos kezelés
    9. A koraszületés komplikációi
    10. Biztonságosság és tolerálhatóság
    11. Farmakokinetika
    12. Légzőszervi neurológiai és kognitív mérések
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 28 days of life; 36 weeks postmenstrual age; 2 years of life
    2. 36 weeks postmenstrual age
    3. Baseline, days 5/10/21 following first dose
    4. Discharge from hospital
    5. Baseline, days 5/10/21 following first dose
    6. Baseline, day 21 following first dose
    7. Baseline, day 21 following first dose
    8. Until discharge from hospital
    9. Until discharge from hospital
    10. Until discharge from hospital
    11. Days 1, 3 and 5 following first dose
    12. 24 months corrected age
    1. 28 napos életkor; 36. postmenstruális hét; 2 éves életkor
    2. 36. postmenstruális hét
    3. Kezdés (baseline), az első kezelési dózist követő 5., 10., 21. nap
    4. Kórházi elbocsájtás
    5. Kezdés (baseline), az első kezelési dózist követő 5., 10., 21. nap
    6. Kezdés (baseline), az első kezelési dózist követő 21. nap
    7. Kezdés (baseline), az első kezelési dózist követő 21. nap
    8. Kórházi elbocsájtásig
    9. Kórházi elbocsájtásig
    10. Kórházi elbocsájtásig
    11. Az első dózist követő 1., 3., és 5. nap
    12. Korrigált 24 hónapos életkor
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    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
    LVLS
    Utolsó beteg utolsó vizitje
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 810
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 810
    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) No
    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 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 neonates
    Koraszülöttek
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 810
    F.4.2.2In the whole clinical trial 810
    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
    A helyi újszülött ellátásra vonatkozó standard ellátás.
    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 Decision2014-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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