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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-001008-13
    Sponsor's Protocol Code Number:SUPERIOR
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-15
    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 ConcernedGreece - EOF
    A.2EudraCT number2018-001008-13
    A.3Full title of the trial
    A SUPAR GUIDED DOUBLE BLIND RANDOMIZED CLINICAL TRIAL OF INITIATION OF ANTIBIOTICS FOR PRESUMED INFECTION AT THE EMERGENCY DEPARTMENT: THE SUPERIOR TRIAL
    ΜΙΑ ΔΙΠΛΗ-ΤΥΦΛΗ ΤΥΧΑΙΟΠΟΙΗΜΕΝΗ ΚΛΙΝΙΚΗ ΜΕΛΕΤΗ ΓΙΑ ΤΗΝ ΚΑΤΕΥΘΥΝΟΜΕΝΗ ΜΕ ΤΗ ΧΡΗΣΗ ΤΟΥ ΒΙΟΔΕΙΚΤΗ SUPAR ΕΝΑΡΞΗ ΧΟΡΗΓΗΣΗΣ ΑΝΤΙΒΙΟΤΙΚΩΝ ΣΕ ΥΠΟΨΙΑ ΛΟΙΜΩΞΗΣ ΣΤΟ ΤΜΗΜΑ ΕΠΕΙΓΟΝΤΩΝ ΠΕΡΙΣΤΑΤΙΚΩΝ: ΜΕΛΕΤΗ SUPERIOR
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial for a guided early administration of antibiotics for presumed infection at the ER
    Μία κλινική μελέτη για κατευθυνόμενη πρώιμη χορήγηση αντιβιοτικών σε υποψία λοίμωξης στα ΤΕΠ
    A.3.2Name or abbreviated title of the trial where available
    SUPERIOR
    A.4.1Sponsor's protocol code numberSUPERIOR
    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 SponsorHELLENIC INSTITUTE FOR THE STUDY OF SEPSIS
    B.1.3.4CountryGreece
    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 supportHELLENIC INSTITUTE FOR THE STUDY OF SEPSIS
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHELLENIC INSTITUTE FOR THE STUDY OF SEPSIS
    B.5.2Functional name of contact pointKIRIAKI KANELLAKOPOULOU
    B.5.3 Address:
    B.5.3.1Street Address ΜΙCHALAKOPOULOU STR. 88
    B.5.3.2Town/ city ATHENS
    B.5.3.3Post code115 28
    B.5.3.4CountryGreece
    B.5.4Telephone number+30210 74 80 662
    B.5.5Fax number+30210 74 80 662
    B.5.6E-mailinsepsis@otenet.gr
    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 MERONEM PD.I.S.INF 1000MG/VIAL(IV) BTx10 VIALS
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca A.E.
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    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 solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInfusion
    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
    Α suPAR guided early antibiotic administration at the Emergency Room for presumed infection and sepsis and evaluation of the impact of this intervention to the patients’ final outcome
    Μία πρώιμη χορήγηση αντιβιοτικών στο Τμήμα Επειγόντων Περιστατικών σε ασθενείς με υποψία λοίμωξης και σήψης βάση των τιμών του suPAR καθώς και αξιολογήση της εν λόγω παρέμβασης στην τελική έκβαση των ασθενών.
    E.1.1.1Medical condition in easily understood language
    Α biomarker guided early antibiotic administration to patients with presumed infection and/or sepsis
    Μία πρώιμη χορήγηση αντιβιοτικών καθοδηγούμενη από βιοδείκτη σε ασθενείς με υποψία λοίμωξης ή σήψης.
    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 PT
    E.1.2Classification code 10040047
    E.1.2Term Sepsis
    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
    The aim of the current study is to evaluate suPAR - guided medical intervention, consisting of early antibiotic administration at the emergency room for presumed infection and sepsis and evaluate the impact of this intervention to the patients’ final outcome. Since the traditionally used biomarkers (PCT, CRP) and scores (SOFA score) for early recognition of severity of infection fail to achieve maximum accuracy in all cases, suPAR levels are assessed as a probably better prognostic rule for early recognition of severe infections.
    Ο σκοπός της παρούσας μελέτης είναι να εκτιμήσει την θεραπευτική παρέμβαση που καθοδηγείται με βάση τις τιμές του suPAR και η οποία συνίσταται σε πρώιμη χορήγηση αντιβιοτικών στο Τμήμα Επειγόντων Περιστατικών σε υποψία λοίμωξης και σήψη καθώς και να αξιολογήσει την επίδραση της εν λόγω παρέμβασης στην τελική έκβαση των ασθενών. Καθώς οι βιοδείκτες (PCT, CRP) και οι κλίμακες (SOFA score) που χρησιμοποιούνται παραδοσιακά για την πρώιμη εκτίμηση της σοβαρότητας της λοίμωξης αδυνατούν να εξασφαλίσουν υψηλό επίπεδο βεβαιότητας σε όλες τις περιπτώσεις, θα εκτιμηθεί το κατα πόσο τα επίπεδα του suPAR μπορούν να αποτελούν έναν καλύτερο προγνωστικό κανόνα για την πρώιμη αναγνώριση των σοβαρών λοιμώξεων.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Written informed consent provided by the patient or by their legal representative in case of patients unable to consent
    Age equal to or above 18 years
    Male or female gender
    Clinical suspicion of infection
    qSOFA equal to 1 point
    suPAR blood level equal or above 12 ng/ml
    Έγγραφη συγκατάθεση του ασθενούς ή του νόμιμου εκπροσώπου του στην περίπτωση που αδυνατεί ο ασθενής να συναινέσει
    Ηλικία μεγαλύτερη ή ίση των 18 ετών
    Άρρεν ή θήλυ φύλο
    Κλινική υποψία λοίμωξης
    Βαθμός qSOFA ίσος με 1
    Τιμή suPAR στο αίμα μεγαλύτερη ή ίση των 12 ng/ml
    E.4Principal exclusion criteria
    Denial to consent
    Patients with 2 or 3 qSOFA signs
    Pregnancy (confirmed by blood or urinary pregnancy test) for female patients of reproductive age
    Organ transplantation
    Fully-blown sepsis with overt failing organs necessitating immediate resuscitation as defined by the attending physicians
    Do not resuscitate decision
    Άρνηση έγγραφης συγκατάθεσης
    Ασθενής με 2 ή 3 σημεία του qSOFA
    Εγκυμοσύνη (επιβεβαιωμένη με αιματολογικές εξετάσεις ή τεστ εγκυμοσύνης ούρων) για γυναίκες αναπαραγωγικής ηλικίας
    Μεταμόσχευση οργάνου
    Πλήρως εγκατεστημένη σήψη με ανεπάρκεια οργάνων που απαιτεί άμεση αναζωογόνηση όπως καθορίζεται από τους εφημερεύοντες ιατρούς
    Κάθε απόφαση μη αναζωογόνησης του ασθενούς
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoint will be the comparative efficacy of the applied intervention versus standard practice on the early worsening of the patient. This is defined as any at least one point increase of the admission total SOFA score the first 24 hours.
    Ως πρωτογενές καταληκτικό σημείο ορίζεται η αποτελεσματικότητα της παρέμβασης με βάση το suPAR σε σύγκριση με την καθιερωμένη θεραπεία στην πρόληψη της πρώιμης επιδείνωσης του ασθενούς. Ως πρώιμη επιδείνωση ορίζεται κάθε αύξηση της συνολικής βαθμολογίας SOFA εισαγωγής στη μελέτη κατά ένα τουλάχιστον βαθμό τις πρώτες 24 ώρες .
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours
    24 ώρες
    E.5.2Secondary end point(s)
    The comparative efficacy of the applied intervention versus standard practice on:
    The early worsening of the patient defined as for the primary endpoint but analyzed separately per quartile of the total SOFA score of the patient population
    7-day, 28-day, 60-day and 90-day mortality
    28-day mortality for patients meeting the Sepsis-3 definition of sepsis
    Time to infection resolution
    Change of initial treatment
    Duration of hospitalization
    Rate of new infections within the following 90 days
    Η αποτελεσματικότητα της παρέμβασης με βάση το suPAR σε σύγκριση με την καθιερωμένη θεραπεία στα κάτωθι:
    Πρώιμη επιδείνωση του ασθενούς, όπως ορίζεται για το πρωτογενές καταληκτικό σημείο, ξεχωριστά για κάθε τεταρτημόριο κατανομής των ασθενών σύμφωνα με τη συνολική βαθμολογία SOFA εισαγωγής
    Θνητότητα μετά 7, 28, 60 και 90 ημέρες
    Η θνητότητα στις 28 ημέρες σε ασθενείς που πληρούν τον ορισμό της σήψης κατά Sepsis-3
    Ο χρόνος μέχρι τη λύση της λοίμωξης
    Η τροποποίηση της αρχικής θεραπείας
    Η διάρκεια της νοσηλείας
    Η συχνότητα εμφάνισης νέας λοίμωξης εντός 90 ημερών
    E.5.2.1Timepoint(s) of evaluation of this end point
    7,28,60, 90 days
    7,28,60, 90 ημέρες
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned2
    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
    Τελευταία επίσκεψη του τελευταίου ασθενή που θα ενταχθεί
    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 months8
    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.1.2.1Number of subjects for this age range: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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
    Patients who cannot see and/or write
    Ασθενείς που δε μπορούν να δουν ή/και να γράψουν
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state220
    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
    καμία
    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 Decision2018-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-29
    P. End of Trial
    P.End of Trial StatusCompleted
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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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