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    Summary
    EudraCT Number:2016-000136-17
    Sponsor's Protocol Code Number:Target_ZKSJ0085
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-04-08
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-000136-17
    A.3Full title of the trial
    Prospective, randomized, multicenter clinical trial on the impact of Therapeutic Drug Monitoring (TDM) of piperacillin on organ functions and survival in the treatment of severe sepsis or septic shock
    Therapeutic drug monitoring-based dose optimisation of piperacillin in patients with severe sepsis or septic shock: a prospective, multicenter, randomised controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Measurement of the blood concentration of the antibiotic piperacillin and individual drug dosage in patients having a severe sepsis oder a septic shock
    Bestimmung der Konzentration des Antibiotikums Piperacillin im Blut bei Patienten mit schwerer Sepsis oder einem Septischen Schock mit individueller Dosisanpassung
    A.3.2Name or abbreviated title of the trial where available
    Target
    A.4.1Sponsor's protocol code numberTarget_ZKSJ0085
    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 SponsorFriedrich Schiller University Jena
    B.1.3.4CountryGermany
    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 supportBMBF
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJena University Hospital, Center for Clinical Studies
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressSalvador-Allende-Platz 27
    B.5.3.2Town/ cityJena
    B.5.3.3Post code07747
    B.5.3.4CountryGermany
    B.5.4Telephone number+4936419396620
    B.5.5Fax number+4936419399969
    B.5.6E-mailZKS-Projektmanagement@med.uni-jena.de
    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.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namePiperacillin/Tazobactam
    D.3.2Product code Pip/Taz
    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 INNPiperacillin
    D.3.9.1CAS number 59703-84-3
    D.3.9.3Other descriptive namePIPERACILLIN SODIUM
    D.3.9.4EV Substance CodeSUB03840MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTazobactam
    D.3.9.1CAS number 89785-84-2
    D.3.9.3Other descriptive nameTAZOBACTAM SODIUM
    D.3.9.4EV Substance CodeSUB04682MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,5
    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 with a severe sepsis oder a septic shock treatet with piperacillin/tazobactam
    Patienten mit einer schweren Sepsis oder einem septischen Schock, die mit Piperacillin/Tazobactam behandelt werden
    E.1.1.1Medical condition in easily understood language
    Patients with a severe sepsis oder a septic shock treatet with the antibiotic piperacillin/tazobactam
    Patienten mit einer schweren Sepsis oder einem septischen Schock, die mit dem Antibiotikum Piperacillin/Tazobactam behandelt werden
    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
    As the primary goal of the study, it needs to be established whether an optimisation of antimicrobial therapy by individual dose adjustment of the test substance Piperacillin has a beneficial impact on organ function in severe sepsis or septic shock and whether it is superiour to dosage following prescribing information. This should be examined on the basis of global morbidity measurement (mean total SOFA-score).
    Als primäres Studienziel ist zu prüfen, ob eine Optimierung der antimikrobiellen Therapie mittels patientenindividueller Dosisanpassung der Prüfsubstanz Piperacillin einen günstigen Einfluss auf die Organfunktionen bei schwerer Sepsis oder septischem Schock hat und einer Dosierung nach Fachinformation überlegen ist. Dies soll anhand eines globalen Morbiditätsmaßes (mittlerer totaler SOFA-Score) untersucht werden.
    E.2.2Secondary objectives of the trial
    • SOFA-Subscores
    Impact of intervention on
    • 28-day mortality
    • duration and cumulative dose of antibiotic therapy
    • number of dose adjustment/treatment cycle
    • days without antibiotics
    • time spent on intensive care unit
    • time spent in hospital
    • days without vasopressors
    • days without renal replacement therapy
    • days without mechanical ventilation
    • safety (side effects)
    • antibiotic therapy costs
    Einfluss der Intervention auf
    • SOFA-Subscores
    • 28-Tage Mortalität
    • Dauer und kumulative Dosis der Antibiotikatherapie
    • Anzahl Dosisanpassungen/Therapiezyklus
    • Antibiotikafreie Tage
    • Verweildauer auf Intensivstation
    • Krankenhausverweildauer
    • Tage ohne Vasopressoren
    • Tage ohne Nierenersatzverfahren
    • Tage ohne mechanischen Beatmung
    • Sicherheit (Nebenwirkungen)
    • Kosten der Antibiotikatherapie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with severe sepsis or septic shock
    • onset of severe sepsis or septic shock not longer than 24 hours prior to randomization
    • Antimicrobial therapy with piperacillin planned or started
    • age ≥18 years
    • written informed consent of the patient or legal representative
    • Vorliegen einer schweren Sepsis oder eines septischen Schocks
    • Beginn der schweren Sepsis bzw. des septischen Schocks nicht länger zurückliegend als 24 Stunden vor Randomisierung
    • geplante oder gestartete antimikrobielle Therapie mit Piperacillin
    • Alter ≥18 Jahre
    • Schriftliche Einwilligungserklärung des Patienten/der Patientin oder dessen/deren gesetzlicher Betreuer oder Bevollmächtigter
    E.4Principal exclusion criteria
    • pregnant or breast-feeding women
    • anamnestic known hypersensitivity against beta-lactam antibiotics or another part of the investigational medicinal product
    • previous treatment with piperacillin (in combination with tazobactam) > 24 hours before randomization
    • participation in another interventional clinical trial
    • previous participation (TARGET)
    • limits of therapy or cessation
    • impaired liver function (Child-Pugh C)
    • life expectancy < 28 day due to accompanying illnesses
    • piperacillin-measurement impossible within 24 hours after randomization
    • Schwangerschaft / Stillzeit
    • Anamnestisch bekannte Überempfindlichkeit gegen ß-Laktam Antibiotika oder gegen einen der sonstigen Bestandteile der Prüfsubstanz
    • Vorbehandlung mit Piperacillin (in Kombination mit Tazobactam) >24h vor Randomisierung
    • Teilnahme des Patienten an einer anderen interventionellen klinischen Prüfung
    • Vorherige Studienteilnahme (TARGET)
    • Therapiebeschränkung oder –einstellung
    • eingeschränkte Leberfunktion (Child-Pugh C)
    • Lebenserwartung < 28 Tage aufgrund von Nebenerkrankungen
    • Piperacillin-Messung innerhalb von 24 Stunden nach Randomisierung nicht möglich
    E.5 End points
    E.5.1Primary end point(s)
    mean total SOFA-Score – from 1st day after randomization until ICU-discharge or dead, but only until 10th day after randomisation
    SOFA-Score - individuell gemittelt von Tag 1 nach Randomisierung bis zur Entlassung von der ITS oder bis zum Tod, jedoch maximal bis Tag 10
    E.5.1.1Timepoint(s) of evaluation of this end point
    daily from randomisation day until 10th day after randomisation
    täglich ab Randomisierung bis Tag 10 nach Randomisierung
    E.5.2Secondary end point(s)
    • SOFA-Subscores
    • 28-day mortality
    • duration and cumulative dosage of antibiotic therapy
    • number of dose adjustment / therapy cycle
    • days without antibiotic, maximum day 14
    • Length of ICU stay, maximum day 28
    • Length of hospital stay, maximum day 28
    • days without vasopressor, maximum day 14
    • days without renal replacement therapy until day 28
    • days without mechanical ventilation until day 28
    • safety (side effects)
    • antibiotic therapy costs
    • SOFA-Subscores
    • 28-Tage Mortalität
    • Dauer und kumulative Dosis der Antibiotikatherapie
    • Anzahl Dosisanpassungen/Therapiezyklus
    • Antibiotikafreie Tage bis maximal Tag 14
    • Verweildauer auf Intensivstation bis maximal Tag 28
    • Krankenhausverweildauer bis maximal Tag 28
    • Tage ohne Vasopressoren bis Tag 14
    • Tage ohne Nierenersatzverfahren bis Tag 28
    • Tage ohne mechanische Beatmung bis Tag 28
    • Sicherheit (Nebenwirkungen)
    • Kosten der Antibiotikatherapie
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the overall study period and day 28, respectively
    Im Studienverlauf bzw. Tag 28
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    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 Yes
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Vergleich von Standard-Therapie mit Dosierung nach Fachinformation und individueller Dosisanpassung
    Comparison of standard therapy with dosage based on prescribing information and individual dosage
    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 concerned15
    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 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
    LVLS
    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 months8
    E.8.9.1In the Member State concerned 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: 176
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 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 2016-04-08. 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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    It can be assumed that there will mainly be patients unable to give a consent, because of the severity of the disease severe sepsis/ septic shock.
    Es ist davon auszugehen, dass es sich wegen der Schwere der Erkrankung schwere Sepsis/ septischer Schock größtenteils um nicht einwilligungsfähige Patienten handelt.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state276
    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. A specific after-treatment is not required. The study intervention is a intensive-care measure without consequence on the following medical care.
    Keine. Eine spezifische Nachbetreuung ist nicht erforderlich. Bei den Studieninterventionen handelt es sich um intensivmedizinische Maßnahmen, die für die anschließende medizinische Betreuung ohne Konsequenz sind.
    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 Decision2016-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-06
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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