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    Summary
    EudraCT Number:2017-002508-29
    Sponsor's Protocol Code Number:CEFTAROPROPH
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-12-04
    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 ConcernedAustria - BASG
    A.2EudraCT number2017-002508-29
    A.3Full title of the trial
    Ceftaroline (Zinforo®) as antibiotic prophylaxis for CABG-surgery: An In-vivo microdialysis study
    Ceftarolin (Zinforo®), ein Cephalosporin der 5. Generation, als perioperative Antibiotikaprophylaxe bei Koronarbypass-Operationen: Eine In-vivo Mikrodialyse Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ceftaroline (Zinforo®) as antibiotic prophylaxis for coronary bypass surgery: An In-vivo microdialysis study
    Ceftarolin (Zinforo®), ein Cephalosporin der 5. Generation, als perioperative Antibiotikaprophylaxe bei Koronarbypass-Operationen: Eine In-vivo Mikrodialyse Studie
    A.4.1Sponsor's protocol code numberCEFTAROPROPH
    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 SponsorMedUni Vienna, Dept of Anesthesia, Critical Care, Div. of Cardiothoracic and Vascular Anesthesia
    B.1.3.4CountryAustria
    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 supportMedical University Vienna
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University Vienna
    B.5.2Functional name of contact pointDepartment of Cardiac Anaesthesia
    B.5.3 Address:
    B.5.3.1Street AddressSpitalgasse 23
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.6E-mailmaximilian.edlinger-stanger@meduniwien.ac.at
    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 Zinforo
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ireland Pharmaceuticals Operations Services Group
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Powder for concentrate for solution for injection/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 INNceftaroline
    D.3.9.1CAS number 229016-73-3
    D.3.9.2Current sponsor codeCEFTAROPROPH
    D.3.9.3Other descriptive nameCEFTAROLINE FOSAMIL
    D.3.9.4EV Substance CodeSUB31648
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Antibiotic prophylaxis for CABG surgery
    Antibiotikaprophylaxe bei CABG Operationen
    E.1.1.1Medical condition in easily understood language
    Antibiotic prophylaxis for coronary bypass surgery
    Antibiotikaprophylaxe bei Koronarbypass Operationen
    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 10036894
    E.1.2Term Prophylactic antibiotic therapy
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To measure free, microbiologically active concentrations of ceftaroline in plasma, subcutaneous tissue and lung parenchyma in order to evaluate whether adequate concentrations of ceftaroline are achieved in this special cohort of patients for antibiotic prophylaxis and treatment of complicated skin and soft-tissue infections and community acquired pneumonia.
    E.2.2Secondary objectives of the trial
    - To compare free concentrations of ceftaroline in subcutaneous tissue with a presumed perfusion deficit (on the left side of sternotomy incision due to LIMA preparation) and subcutaneus tissue with normal perfusion (on the right side of the sternotomy incision)

    - To compare bolus- and continuous administration of ceftaroline using identical doses
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Written informed consent
    -Planned coronary artery bypass grafting with left internal mammary artery bypass
    -Planned use of cardiopulmonary bypass
    -Age: > 18 and < 90 years
    -Ejection fraction > 40%
    E.4Principal exclusion criteria
    -Inability to give informed consent
    -Know allergy to cephalosporins or penicillin or ceftaroline
    -Preoperative antibiotic therapy
    -Signs of infection preoperatively
    -Re-operation or emergency procedure
    -Planned use of bilateral internal mammary artery bypass
    -Preoperative renal failure
    -Chronic severe renal insufficiency including hemodialysis
    -Chronic severe liver disease
    -BMI > 35
    -Long standing diabetes mellitus (> 7 years) and insulin-dependent diabetes mellitus
    -Pregnant women
    E.5 End points
    E.5.1Primary end point(s)
    - Perioperative pharmacokinetic profiles of ceftaroline in plasma, subcutaneous tissue and lung parenchyma
    E.5.1.1Timepoint(s) of evaluation of this end point
    In the bolus-group, ceftaroline plasma and tissue concentrations will be drawn at baseline, in 30min intervals during administration of each bolus and every 2h after completion of the bolus until the next bolus. The last sample will be drawn 1440mins after the first administration.
    In the continuous group, ceftaroline plasma and tissue concentrations will be drawn at baseline, in 30min intervals for the first 10h of continuous adminstration and every 2h thereafter until 1440mins after the first administration.
    E.5.2Secondary end point(s)
    - Difference of pharmacokinetics of ceftaroline between plasma, subcutaneous tissue and lung parenchyma
    - Difference of pharmacokinetic profiles between intermittent bolus administration and continuous administration of ceftaroline
    E.5.2.1Timepoint(s) of evaluation of this end point
    In the bolus-group, ceftaroline plasma and tissue concentrations will be drawn at baseline, in 30min intervals during administration of each bolus and every 2h after completion of the bolus until the next bolus. The last sample will be drawn 1440mins after the first administration.
    In the continuous group, ceftaroline plasma and tissue concentrations will be drawn at baseline, in 30min intervals for the first 10h of continuous adminstration and every 2h thereafter until 1440mins after the first administration.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Bolus administration vs continuous administration of ceftaroline
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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.1.3Elderly (>=65 years) Yes
    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 Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-23
    P. End of Trial
    P.End of Trial StatusOngoing
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