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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   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:2015-001706-34
    Sponsor's Protocol Code Number:D5470C00004
    National Competent Authority:Croatia - MIZ
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-06
    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 ConcernedCroatia - MIZ
    A.2EudraCT number2015-001706-34
    A.3Full title of the trial
    A Phase 2 Proof-of-concept Study to Evaluate the Efficacy and Safety of MEDI3902 in Mechanically Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomonas aeruginosa.
    Ispitivanje 2. faze za dokazivanje koncepta i procjenu učinkovitosti i sigurnosti lijeka MEDI3902 za prevenciju bolničke upale pluća izazvane bakterijom Pseudomonas aeruginosa u mehanički ventiliranih ispitanika
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial looking at the safety and efficacy of MEDI3902 in the prevention of Pseudomonas aeruginosa pneumonia occurring in the hospital
    Ispitivanje učinkovitosti i sigurnosti lijeka MEDI3902 za prevenciju bolničke upale pluća izazvane bakterijom Pseudomonas aeruginosa
    A.3.2Name or abbreviated title of the trial where available
    EVADE
    A.4.1Sponsor's protocol code numberD5470C00004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02696902
    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 SponsorMedImmune, LLC
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedImmune, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressOne MedImmune Way
    B.5.3.2Town/ cityGaithersburg
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 301 398 0000
    B.5.6E-mailinformationcenter@astrazeneca.com
    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.2.5The 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 nameMEDI3902
    D.3.2Product code MEDI3902
    D.3.4Pharmaceutical form 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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeMEDI3902
    D.3.9.3Other descriptive nameMEDI3902
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa
    Prevencija nozokomijalne pneumonije uzrokovane sa Pseudomonas aeurginosa
    E.1.1.1Medical condition in easily understood language
    Prevention of Pseudomonas aeruginosa pneumonia occurring in the hospital
    Prevencija bolničke pneumonije uzrokovane sa Pseudomonas aeurginosa
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10051190
    E.1.2Term Pneumonia Pseudomonas aeruginosa
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1.To evaluate the effect of MEDI3902 in reducing the incidence of nosocomial pneumonia
    caused by P aeruginosa
    2. To evaluate the safety of a single IV dose of MEDI3902 in mechanically ventilated patients
    E.2.2Secondary objectives of the trial
    1. To evaluate the serum pharmacokinetics (PK) of MEDI3902
    2. To evaluate the serum anti-drug antibody (ADA) responses to MEDI3902
    1. Procijeniti učinak lijeka MEDI3902 u smanjenju učestalosti bolničke upale pluća izazvane bakterijom P. aeruginosa.
    2. Procijeniti sigurnost jedne intravenske doze lijeka MEDI3902 u mehanički ventiliranih ispitanika.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Colonized with Pseudomonas aeruginosa in respiratory tract, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.
    1. Muškarci i žene stariji od 18 godina u trenutku uključivanja u ispitivanje.
    2. Potpisani informirani pristanak od strane ispitanika ili zakonskog zastupnika prije provođenja bilo kojeg postupka iz plana ispitivanja, uključujući i procjene za probir.
    3. Žene koje mogu zatrudnjeti i koje su spolno aktivne s nesteriliziranim muškim partnerima moraju imati dokaz da u trenutku uključivanja nisu trudne te moraju imati negativan test na trudnoću prije primanja ispitivanog lijeka.
    a. Žene koje mogu zatrudnjeti definiraju se kao žene koje nisu kirurški sterilizirane (podvezivanjem oba jajovoda ili potpunim odstranjenjem maternice) ili one koje nisu u premenarhalnoj dobi ili u postmenopauzi (definiranoj kao 12 mjeseci bez mjesečnice bez nekog drugog medicinskog uzroka).
    4. Trenutačno intubirani bolesnici priključeni na mehaničku ventilaciju u odjelu za intenzivnu njegu.
    5. Prikupljeni trahealni uzorak pozitivan na lančanu reakciju polimeraze za P. aeruginosa u 36 sati prije randomizacije.
    6. Očekivanje trajanja intubacije i mehaničke ventilacije ≥ 72 sata na temelju procjene ispitivača.
    7. Nepostojanje dijagnoze novog nastupa upale pluća u 72 sata prije randomizacije (ispitanici s dokazom izliječene upale pluća bit će podobni za ispitivanje).
    8. Očekivano preživljavanje prema procjeni ispitivača > 2 tjedna.
    9. Očekivano sudjelovanje u ispitivanju do 49. dana nakon primanja lijeka.
    E.4Principal exclusion criteria
    Pseudomonas disease at randomisation; lung injury score consistent with pneumonia; current lung disease; currently receiving protocol-specified anti-pseudomonal antibiotics; moribund patients.
    1. Potvrđena ili pretpostavljena akutna bolest izazvana bakterijom Pseudomonas u trenutku uključivanja u ispitivanje i primanja ispitivanog lijeka (endotrahealna kolonizacija je prihvatljiva i potrebna [pogledati 5. kriterij za uključivanje]).
    2. Klinička skala plućne infekcije (CPIS) ≥ 6 na temelju kontributivnih parametara izmjerenih u prošla 24 sata prije davanja ispitivanog lijeka (Prilog 4).
    3. Aktivna plućna bolest koja bi onemogućavala dijagnosticiranje upale pluća, poput aktivne tuberkuloze, gljivične bolesti, opstruktivnog raka pluća, velikog pleularnog izljeva ili empijema, cistične fibroze ili sindroma akutnog respiratornog distresa s „izbjeljenjem“ pluća.
    4. Ispitanici kojima je prije sadašnjeg prijema u bolnicu napravljena traheostomija.
    5. Primanje antibiotika koji se smatraju aktivnim protiv soja bakterije P. aeruginosa kojom je bolesnik koloniziran tijekom > 72 sata u 96 sati prije randomizacije ili predviđanje tekuće primjene antibiotika protiv bakterije P. aeruginosa.
    6. Opekline na > 40 % površine tijela.
    7. Rezultat Procjene akutne fiziologije i kroničnog zdravlja II (APACHE-II) ≥ 25 ili rezultat Procjene zatajenja organa povezanog sa sepsom (SOFA) ≥ 9 u trenutku randomizacije (Prilozi 5 i 6). Vazopresori korišteni za poboljšanje cerebralnog perfuzijskog tlaka (na primjer, zbog subarahnoidalne hemoragije) ne trebaju se koristiti u izračunu kardiovaskularne komponente rezultata SOFA.
    8. Primanje bilo kojeg drugog ispitivanog lijeka u 30 dana prije davanja ovog ispitivanog lijeka.
    9. Prethodno primanje monoklonskih antitijela.
    10. Bolesnici zaraženi HIV-om čija infekcija prema mišljenju ispitivača nije dobro kontrolirana. Ispitanici s poviješću infekcije HIV-om koji su primali visokoučinkovitu antiretroviralnu terapiju i koji najmanje 6 mjeseci nemaju simptome infekcije HIV-om mogu se uključiti u ispitivanje.
    11. Bolesnici kojima limfom nije u potpunoj remisiji i primaju kemoterapiju.
    12. Bolesnici kojima je presađena koštana srž, matične stanice ili čvrsti organi koji trenutačno nisu u potpunoj remisiji.
    13. Primanje kemoterapije ili drugih imunosupresiva uključujući terapiju glukokortikoidima (20 mg prednizona ili ekvivalent svaki ili svaki drugi dan tijekom 30 dana) u zadnja 2 mjeseca.
    14. Povijest poznate preosjetljivosti na bilo koji sastojak ispitivanog lijeka.
    15. Trudnice i dojilje.
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence of nosocomial pneumonia caused by P aeruginosa

    - Treatment emergent adverse events (TEAEs) treatment emergent serious adverse events (TESAEs), adverse events of special interest (AESIs) through 49 days postdose
    Učinkovitost
    1. Učestalost bolničke upale pluća izazvane bakterijom P. aeruginosa do 21. dana nakon primanja lijeka.
    Sigurnost
    1. Štetni događaji proizašli iz liječenja, ozbiljni štetni događaji proizašli iz liječenja i štetni događaji od posebnog interesa do 49. dana nakon primanja lijeka.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through 49 days postdose
    Do 49. dana nakon primanja ispitivanog lijeka
    E.5.2Secondary end point(s)
    1. MEDI3902 serum concentration and PK parameters
    2. MEDI3902 ADA response in serum
    1. Koncentracija lijeka MEDI3902 u serumu i farmakokinetički parametri do 49. dana nakon primanja lijeka.
    2. Odgovor antitijela protiv lijeka MEDI3902 u serumu do 49. dana nakon primanja lijeka.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through 49 days postdose
    Do 49. dana nakon primanja ispitivanog lijeka
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Croatia
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Ireland
    Israel
    Portugal
    Slovakia
    Spain
    Switzerland
    Turkey
    United Kingdom
    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
    End of trial is last subject last visit
    Posljednji posjet posljednje uključenog ispitanika
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 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: 143
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 143
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Mechanically ventilated adult subjects.
    Mehanički ventilirani odrasli ispitanici
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 241
    F.4.2.2In the whole clinical trial 286
    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)
    After the study the patients should revert to standard of care.
    Poslije ispitivanja ispitanici će primati standardno liječenje
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation COMBACTE-MAGNET (Combatting Bacterial Resistance in Europe - Molecules against Gram Negative Infections)
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-04
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