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    Summary
    EudraCT Number:2013-003914-42
    Sponsor's Protocol Code Number:CEFTAROLINE_RRT
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-09-24
    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 number2013-003914-42
    A.3Full title of the trial
    Multiple-dose Pharmacokinetics of Ceftaroline during continuous and intermittent renal replacement therapy in patients requiring renal replacement therapy
    Bestimmung von Blutkonzentrationen von Ceftarolin während kontinuierlicher und intermittierender Nierenersatzverfahren bei Patienten die eines Nierenersatzverfahrens bedürfen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Blood concentration of Ceftaroline during renal replacement therapy
    Bestimmung der Blutspiegel von Ceftarolin während Nierenersatzverfahren
    A.3.2Name or abbreviated title of the trial where available
    CEFTAROLINE_RRT
    A.4.1Sponsor's protocol code numberCEFTAROLINE_RRT
    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 SponsorMedizinische Universität Wien, Univ.-Klinik für Innere Medizin I, Klinische Abteilung für Infetionen und Tropenmedizin
    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 of Vienna
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Wien, Univ.-Klinik für Innere Medizin I, Klinische Abteilung für Infetionen und Tropenmedizin
    B.5.2Functional name of contact pointFlorian Thalhammer
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number00431404004440
    B.5.6E-mailflorian.thalhammer@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 holderAstraZeneca
    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.3.1Product nameZinforo
    D.3.4Pharmaceutical form Powder 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 INNCeftaroline fosamil
    D.3.9.1CAS number 400827-46-5
    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
    Bacterial infection in patients recieving renal replacement therapy
    Bakterielle Infektionen bei Patienten welche eine Nierenersatztherapie benötigen
    E.1.1.1Medical condition in easily understood language
    Bacterial infection in patients recieving renal replacement therapy
    Bakterielle Infektionen bei Patienten welche eine Nierenersatztherapie benötigen
    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 16.0
    E.1.2Level PT
    E.1.2Classification code 10060945
    E.1.2Term Bacterial infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine the correct dosage for Ceftaroline during renal replacement therapy.
    Bestimmung der richtigen Dosierung von Ceftarolin während Nierenersatzverfahren.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Age >18 years
    b) Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
    c) Renal replacement therapy (continuous or intermittent)
    a) Alter >18a
    b) Vermutete oder bewiesene Infektion mit einem auf Ceftarolin empfindlichen Erreger welche parenterale antimikrobielle Therapie erfordert
    c) Nierenersatzverfahren (kontinuierlich oder intermittierend)
    E.4Principal exclusion criteria
    a) Known hypersensitivity to ceftaroline or other cephalosporins, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents.
    b) An expected survival of less than two days.
    c) Known pregnancy
    d) Coadministration of valproic acid or probenecid, which cannot be discontinued for the duration of the study
    e) Ceftarolin as monotherapy for resistent species or fungal infections.
    f) Other reasons oposing the study participation on the discretion of the investigators
    a) Bekannte Überempfindlichkeit gegenüber Ceftarolin oder anderen Cephalosporinen oder bekannte schwere anaphylaktische Reaktionen gegen Betalaktame.
    b) Vermutetes Überleben < 2 Tage
    c) Bekannte Schwangerschaft
    d) Gelichzeitige Gabe von Valproinsäure oder Probenecid, die für die Dauer der Studie nicht unterbrochen werden kann
    e) Ceftarolin als Monotherapie für gegen Ceftarolin resistente Erreger oder Pilzinfektionen
    f) Andere Gründe die eine erfolgreiche Studienteilnahme aus Sicht des Studienarztes unwahrscheinlich machen.
    E.5 End points
    E.5.1Primary end point(s)
    AUC of Ceftaroline during RRT
    AUC von Ceftarolin bei Nierenersatzverfahren
    E.5.1.1Timepoint(s) of evaluation of this end point
    In the intermittent RRT arm: at timepoints 0, 0.5, 1, 2, 3.5, 4 hours and after the end of the frirst dialysis session, and pre-dialysis, post-dialysis and post infusion over 15 days.

    In the continuous arm: at timepoints 0, 0.5, 1, 2, 3.5, 4, 8, 9, 16, 17, 24, 25, 32, 33, 40, 41, 48 and 49 hours starting from the first dose of ceftaroline.
    Im intermittierende RRT Arm: zu den Zeitpunkten 0, 0.5, 1, 2, 3.5, 4 Stunden und nach dem Ende der Dialysesitzung, sowie vor und nach jeder dialysesitzung sowie nach jeder Infusion von Ceftarolin über 14 Tage.

    Im kontinuierliche RRT Arm: zu den Zeitpunkten 0, 0.5, 1, 2, 3.5, 4, 8, 9, 16, 17, 24, 25, 32, 33, 40, 41, 48 und 49 Stunden nach der ersten Ceftarolin Dosis.
    E.5.2Secondary end point(s)
    half-life (t1/2), maximum and minimum plasma concentration (Cmax, Cmin), total body clearance (Cltot), hemofiltration clearance (ClHF), sieving coefficient and the elimination fraction
    Halbwertszeit, höchste und niedrigste Plasmakonzentration, gesamte Körper Clearance, Hämofiltrationsclearance, Siebkoeffizient und Eliminations Fraktion
    E.5.2.1Timepoint(s) of evaluation of this end point
    In the intermittent RRT arm: at timepoints 0, 0.5, 1, 2, 3.5, 4 hours and after the end of the frirst dialysis session, and pre-dialysis, post-dialysis and post infusion over 14 days.

    In the continuous arm: at timepoints 0, 0.5, 1, 2, 3.5, 4, 8, 9, 16, 17, 24, 25, 32, 33, 40, 41, 48 and 49 starting from the first dose of ceftaroline.
    Im intermittierende RRT Arm: zu den Zeitpunkten 0, 0.5, 1, 2, 3.5, 4 Stunden und nach dem Ende der Dialysesitzung, sowie vor und nach jeder dialysesitzung sowie nach jeder Infusion von Ceftarolin über 14 Tage.

    Im kontinuierliche RRT Arm: zu den Zeitpunkten 0, 0.5, 1, 2, 3.5, 4, 8, 9, 16, 17, 24, 25, 32, 33, 40, 41, 48 und 49 Stunden nach der ersten Ceftarolin Dosis.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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 No
    E.8.1.1Randomised No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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
    last visit of the last subject undergoing the trial
    Letzter Besuch des letzten Patienten
    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
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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
    In intensive care patients, consentable patients will give their written informed consent before inclusion into the study, while sedated, non-consentable patients will be informed about the study when they are no longer sedated.
    Auf Intensivstationen liegende Patienten die temporär nicht einwilligungsfähig sein sollten werden umgehend nach Beendigung der Sedierung über die Studie aufgeklärt werden.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    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 Decision2013-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-12-01
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