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    Summary
    EudraCT Number:2017-000934-77
    Sponsor's Protocol Code Number:4.0
    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:2018-04-10
    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 number2017-000934-77
    A.3Full title of the trial
    Target attainment of Cefazolin Continuous Infusion for Antibiotic Prophylaxis in patients undergoing CABG surgery
    Erreichen der Zielspiegel von Cefazolin als kontinuierliche Infusion zur antibiotischen Prophylaxe bei Patienten während einer koronararteriellen Bypass Operation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Continuous Infusion of Cefazolin as Antibiotic Prophylaxis in patients undergoing CABG Surgery
    Cefazolin als kontinuierliche Infusion zur antibiotischen Prophylaxe bei Patienten während einer koronararteriellen Bypass Operation
    A.3.2Name or abbreviated title of the trial where available
    Cefazolin target attainment
    Cefazolin als kontinuierliche Infusion zur antibiotischen Prophylaxe
    A.4.1Sponsor's protocol code number4.0
    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 SponsorMedical University of Vienna
    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 supportAKH Wien,Herzchirurgie
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAKH Wien, Herzchirurgie Abteilung
    B.5.2Functional name of contact pointCefazolin Martin Andreas
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number+4314040047277
    B.5.5Fax number+4314040047030
    B.5.6E-mailarcsoffice@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 Cefazolin 2g
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz GmbH, Austria
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameCefazolin
    D.3.2Product code J01DB04
    D.3.4Pharmaceutical form Powder 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 INNCefazolin
    D.3.9.1CAS number 25953-19-9
    D.3.9.2Current sponsor code1442604-001
    D.3.9.3Other descriptive nameCEFAZOLIN SODIUM
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Patients referred for CABG to the Department of Cardiac Surgery with planned isolated left mammary artery and vein/radial artery grafts preparation will be asked to participate in this trial.
    Patienten, die für die CABG an die Abteilung für Herzchirurgie überwiesen werden, werden gebeten, an dieser Studie teilzunehmen. Sie werden mit einer geplanten isolierten linken Brustarterie und Vene / Radialarterien-Transplantatpräparation versorgt.
    E.1.1.1Medical condition in easily understood language
    Deep sternal wound infections represents a severe complication after cardiac surgery. Patients undergoing CABG are at high for appalling postoperative infections.
    Tiefe Wundinfektionen stellen eine schwere Komplikation nach Herzoperationen dar. Patienten, die sich einer CABG unterziehen, sind bei entsetzlichen postoperativen Infektionen hoch.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    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 penetration in subcutaneous tissue levels of cefazolin continuously given and calculation of target attainment values compared to historical control (primary objective with regard to sample size calculation).
    -Bewertung der Penetration von Cefazolin im subkutanen Gewebe kontinuierlich und Berechnung der Zielerreichungswerte im Vergleich zur historischen Kontrolle(primäres Ziel in Bezug auf die Stichprobengröße)
    E.2.2Secondary objectives of the trial
    Not applicable
    Unzutreffend
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Not applicable
    Unzutreffend
    E.3Principal inclusion criteria
    Written informed consent.
    -Planned coronary artery bypass grafting with isolated left mammary artery bypass and vein grafts.
    -Planned use of cardiopulmonary bypass.
    -Schriftliche Einverständniserklärung.
    -Geplante koronararterien-Bypass-Transplantation mit isoliertem linken Brustarterien-Bypass und Venentransplantaten.
    -Geplante Verwendung des Kardiopulmonalen Bypasses
    E.4Principal exclusion criteria
    -Inability to give informed consent.
    -Know allergy to cephalosporin's, penicillin
    -Re-operation.
    -Preoperative renal failure.
    -Chronic severe renal insufficiency including haemodialysis.
    -BMI > 35.
    -Long standing diabetes mellitus (> 7 years) and insulin-dependent diabetes mellitus.
    -Ejection fraction <20% measured with transthoracic echocardiography.
    -Positive pregnancy test in patients with childbearing potential
    -Unfähigkeit,Einverständniserklärung zu geben
    -Allergien gegen Cephalqsporine,Penicillin
    -Re-betrieb(Re-operation)
    -Preoperatives Nierenversagen
    -Chronische schwere Niereninsuffizienz einschließlich Hämodialyse.
    -BMI>35
    -Ständiger Diabetes mellitus(>7Jahre) und Insulin-abhängiger Diabetes mellitus
    -Einspritzungsfraktion<20% gemessen mit transthorakaler Echokardiographie.
    -Positiv Schwangerschaftstest bei Patienten mir gebärfähigem Potenzial
    E.5 End points
    E.5.1Primary end point(s)
    To assess the potential beneficial effect with regard to target attainment at the side of potential post-surgical infection of an advanced preoperative antibiotic regime. Therefore, target attainment by a continuous infusion regimen of cefazolin (study group 1) will be compared to intermittent dosing (historical control performed by our study group). However, Cefazolin might not be effective in cased where prophylaxis against MRSA strains has to be performed, e.g. when the level of MRSA in the respective hospital is high or when the patient is already pre-colonized with MRSA. Therefore, we plan to test a novel antibiotic substance, namely Dalbavancin, and its tissue perfusion in CABG patients (study group 2). Dalbavancin is highly active against resistant gram-positive pathogens and has a half-life of 8 days, thereby intrinsically reflects the pharmacokinetic properties of continuous exposure which for antibiotic with short half-life has to be achieved by continuous infusion. Thereby we want to evaluate which strategy is best to overcome the perfusion deficit which impairs antibiotic tissue penetration to target tissue during CABG surgery and investigate if Dalbavancin is an alternative in case prophylaxis against MRSA has to be performed.
    Die potenzielle positive Wirkung im Hinblick auf die Zielerreichung auf der Seite der potenziellen postoperativen Infektion eines fortgeschrittenen präoperativen Antibiotikaregimes zu bewerten. Daher wird die Zielerreichung durch ein kontinuierliches Infusionsschema von Cefazolin (Studiengruppe 1) mit einer intermittierenden Dosierung (von unserer Studiengruppe durchgeführte historische Kontrolle) verglichen. Jedoch kann Cefazolin in Fällen, in denen eine Prophylaxe gegen MRSA- Stämme durchgeführt werden muss, z. wenn der MRSA-Spiegel im jeweiligen Krankenhaus hoch ist oder wenn der Patient bereits mit MRSA vorkolonisiert ist. Daher planen wir, eine neuartige antibiotische Substanz, nämlich Dalbavancin, und seine Gewebeperfusion bei CABG- Patienten zu testen (Studiengruppe 2). Dalbavancin ist hochwirksam gegen resistente gram-positive Erreger und hat eine Halbwertszeit von 8 Tagen, was die intrinsischen pharmakokinetischen Eigenschaften einer kontinuierlichen Exposition widerspiegelt, die für ein Antibiotikum mit kurzer Halbwertszeit durch kontinuierliche Infusion erreicht werden muss. Dabei wollen wir herausfinden, welche Strategie am besten geeignet ist, das Perfusionsdefizit zu überwinden, welches die antibiotische Gewebedurchdringung des Zielgewebes während der
    CABG-Operation beeinträchtigt, und zu untersuchen, ob Dalbavancin eine Alternative ist, falls eine Prophylaxe gegen MRSA durchgeführt werden muss.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End point would be evaluated after inclusion of 8 patients for Cefazolin group with exception that before subjects will be included in group. As in the historical group the safety purposes are evaluated right after inclusion the data of this arm will be compared to the historical group.
    Der Endpunkt würde nach Aufnahme von 8 Patienten für die Cefazolin- Gruppe bewertet werden, mit der Ausnahme, dass die Probanden in die Gruppe aufgenommen werden. Da in der historischen Gruppe die Sicherheitszwecke unmittelbar nach der Aufnahme ausgewertet werden, werden die Daten dieses Arms mit der historischen Gruppe verglichen.
    E.5.2Secondary end point(s)
    Not applicable
    Unzutreffend
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    Unzutreffend
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.1.7.1Other trial design description
    Nicht verblendete, Prospektive Studie
    Not blinded,Prospective Study
    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.8.5.1Number of sites anticipated in the EEA1
    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
    If the serious adverse event which has not been listed on the product brochure occurs and ethical board decides the termination of the study, the trial will be stopped. But the number of the patient which has been included will be normally treated like any other patient undergoing bypass and will continue its stay in hospital till the discharge day.
    Wenn das schwerwiegende unerwünschte Ereignis, das nicht in der Produktbroschüre aufgeführt ist, eintritt und die Ethikkommission den Abbruch der Studie beschließt, wird die Studie abgebrochen. Die Anzahl der eingeschlossenen Patienten wird jedoch normalerweise wie jeder andere Patient behandelt, der sich einer Bypass-Operation unterzieht, und bleibt bis zum Entlassungstag im Krankenhaus.
    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 months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months24
    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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 No
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-04-10. Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 8
    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
    Keine
    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 Decision2018-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-20
    P. End of Trial
    P.End of Trial StatusOngoing
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