Clinical Trials Register

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

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A. Protocol Information

A.1

Member State Concerned

Greece - EOF

A.2

EudraCT number

2018-001008-13

A.3

Full 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.3.1

Title 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.3.2

Name or abbreviated title of the trial where available

SUPERIOR

A.4.1

Sponsor's protocol code number

SUPERIOR

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS
B.1.3.4	Country	Greece
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS
B.4.2	Country	Greece
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS
B.5.2	Functional name of contact point	KIRIAKI KANELLAKOPOULOU
B.5.3	Address:
B.5.3.1	Street Address	ΜΙCHALAKOPOULOU STR. 88
B.5.3.2	Town/ city	ATHENS
B.5.3.3	Post code	115 28
B.5.3.4	Country	Greece
B.5.4	Telephone number	+30210 74 80 662
B.5.5	Fax number	+30210 74 80 662
B.5.6	E-mail	insepsis@otenet.gr

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	MERONEM PD.I.S.INF 1000MG/VIAL(IV) BTx10 VIALS
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca A.E.
D.2.1.2	Country which granted the Marketing Authorisation	Greece
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical 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.1.1.1

Medical 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.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10040047
E.1.2	Term	Sepsis
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

Primary 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.5.1.1

Timepoint(s) of evaluation of this end point

24 hours

24 ώρες

E.5.2

Secondary 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.5.2.1

Timepoint(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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

110

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

110

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Patients who cannot see and/or write

Ασθενείς που δε μπορούν να δουν ή/και να γράψουν

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

220

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-07-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-06-29

P. End of Trial
P.	End of Trial Status	Completed

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