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    Summary
    EudraCT Number:2014-001097-34
    Sponsor's Protocol Code Number:CD-ID-MEDI4893-1139
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-25
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-001097-34
    A.3Full title of the trial
    A Phase 2 Randomised, Double-blind, Placebo-controlled,
    Single-dose, Dose-ranging Study of the Efficacy and
    Safety of MEDI4893, a Human Monoclonal Antibody
    Against Staphylococcus aureus Alpha Toxin in
    Mechanically Ventilated Adult Subjects
    Estudio de fase 2, aleatorizado, doble ciego, controlado con placebo, de rango de dosis y de dosis única para evaluar la eficacia y la seguridad de MEDI4893, un anticuerpo monoclonal humano contra la toxina alfa de Staphylococcus aureus, en sujetos adultos sometidos a ventilación mecánica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused by bacterial infection with Staphylococcus aureus in high-risk patients.
    Ensayo clínico para evaluar la seguridad y la eficacia de MEDI4893 en la prevención de la neumonía causada por una infección bacteriana por Staphylococcus aureus en pacientes de alto riesgo.
    A.3.2Name or abbreviated title of the trial where available
    SAATELLITE
    SAATELLITE
    A.4.1Sponsor's protocol code numberCD-ID-MEDI4893-1139
    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 pointClinical Trial Enquiries
    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 number900834223
    B.5.5Fax number/
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 No
    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 nameMEDI4893
    D.3.2Product code MEDI4893
    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 codeMEDI4893
    D.3.9.3Other descriptive nameMEDI4893
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 Staphyloccus aureus pneumonia
    Prevención de neumonía por Staphylococcus aureus
    E.1.1.1Medical condition in easily understood language
    Staphyloccus aureus pneumonia
    Neumonía por Staphylococcus aureus
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10041942
    E.1.2Term Staphylococcus aureus pneumonia
    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
    * To evaluate the effect of MEDI4893 in reducing the incidence of S aureus pneumonia
    * To evaluate the safety of a single IV dose of MEDI4893
    * Evaluar el efecto de MEDI4893 sobre la reducción de la incidencia de neumonía por S. aureus.
    * Evaluar la seguridad de una dosis IV única de MEDI4893.
    E.2.2Secondary objectives of the trial
    * To evaluate the serum pharmacokinetics (PK) of MEDI4893
    * To evaluate the serum anti-drug antibody (ADA) responses to MEDI4893
    * To evaluate the effect of MEDI4893 in reducing the incidence of S aureus pneumonia by mechanical ventilation status
    * Evaluar la farmacocinética (FC) en suero de MEDI4893.
    * Evaluar las respuestas de anticuerpos contra el fármaco (ACF) en suero frente a MEDI4893.
    * Evaluar el efecto de MEDI4893 sobre la reducción de la incidencia de neumonía por S. aureus según el estado de ventilación mecánica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Colonized with S aureus , expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.
    Colonizados por S aureus, se espera requerir intubación y ventilación mecánica prolongada, sin ninguna evidencia de neumonía activa.
    E.4Principal exclusion criteria
    Staphylococcal disease at randomisation; lung injury score consistent with pneumonia; current lung disease; chronic tracheostomy patients; currently receiving systemic anti-staphylococcal antibiotics; moribund patients.
    Enfermedad estafilocócica en el momento de la aleatorización; lesión pulmonar con una puntuación consistente con neumonía; enfermedad pulmonar actual; pacientes crónicos de traqueotomía; actualmente recibiendo antibióticos sistémicos contra estafilococo; pacientes moribundos.
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence of S aureus pneumonia

    2. Safety of MEDI4893
    1. Incidencia de neumonía por S. aureus

    2. Seguridad de MEDI4893
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. 30 Days post dose

    2. TEAEs through 30 days and 90 days post dose, TESAEs, AESIs, NOCDs through 360 days post dose.
    1. 30 días después de la dosis.

    2. Acontecimientos adversos de aparición durante el tratamiento (AAAT) hasta 30 y 90 días después de la dosis, Acontecimientos adversos graves de aparición durante el tratamiento (AAGAT), acontecimientos adversos de interés especial (AAIE) y enfermedades crónicas de nueva aparición (ECNA) hasta 360 días después de la dosis.
    E.5.2Secondary end point(s)
    * MEDI4893 serum PK
    * MEDI4893 ADA response in serum
    * Incidence of S aureus pneumonia on mechanical ventilation
    * Incidence of S aureus pneumonia after extubation
    * FC de MEDI4893 en suero.
    * Respuesta de ACF frente a MEDI4893 en suero.
    * Incidencia de neumonía por S. aureus durante la ventilación mecánica.
    * Incidencia de neumonía por S. aureus después de la ventilación mecánica.
    E.5.2.1Timepoint(s) of evaluation of this end point
    * Serum PK and ADA: 90 days
    * S aureus pneumonia: 30 days
    * FC en suero y ACF: 90 días
    * Neumonía por S. aureus: 30 días
    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 trial3
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    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
    Switzerland
    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.
    Se define el fin de ensayo como la última visita del último paciente.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 231
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 231
    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.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 432
    F.4.2.2In the whole clinical trial 462
    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)
    None.
    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 (Combatting Bacterial Resistance in Europe)
    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 Decision2014-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-02
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