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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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:2007-004333-42
    Sponsor's Protocol Code Number:SISPCT
    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:2008-03-07
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-004333-42
    A.3Full title of the trial
    Prospective randomized clinical multicenter trial about the effect of an adjunctive intravenous treatment with sodium selenite (selenase®T, double-blind) and a procalcitonin guided causal therapy (open) on the survival of patients with severe sepsis and septic shock.
    Prospektive, randomisierte, multizentrische klinische Prüfung zum Einfluss einer adjunktiven intravenösen Therapie mit Natriumselenit (selenase®T, doppelblind) und einer mittels Procalcitonin (offen) gesteuerten kausalen Therapie auf das Überleben von Patienten mit schwerer Sepsis und septischem Schock
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Placebo Controlled Trial of Sodium Selenite and Procalcitonin Guided Antimicrobial Therapy in Severe Sepsis
    Klinische Studie zum Einfluss einer Therapie mit Selen (selenase®T) und mittels Procalcitonin gesteuerter Therapiemaßnahmen auf das Überleben von Patienten mit schwerer Sepsis und septischem Schock
    A.3.2Name or abbreviated title of the trial where available
    SISPCT
    A.4.1Sponsor's protocol code numberSISPCT
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00832039
    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 of 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 supportbiosyn Arzneimittel GmbH
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportThermo Fisher Scientific
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJena University Hospital - Dep. of Anesthesiology and Intensive Care Medicine
    B.5.2Functional name of contact point
    B.5.3 Address:
    B.5.3.1Street AddressErlanger Allee 101
    B.5.3.2Town/ cityJena
    B.5.3.3Post code07747
    B.5.3.4CountryGermany
    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 selenase T pro injectione
    D.2.1.1.2Name of the Marketing Authorisation holderbiosyn Arzneimittel GmbH
    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 nameSelen als Natriumselenitpentahydrat
    D.3.4Pharmaceutical form 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.3.9.1CAS number 10102188
    D.3.9.3Other descriptive nameSODIUM SELENITE PENTAHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboSolution for infusion
    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
    severe sepsis / septic shock
    Schwere Sepsis / Septischer Schock
    E.1.1.1Medical condition in easily understood language
    Sepsis is a complication of infection where organs not involved in the infection are harmed by the patients own immune system. This may cause a vital thread.
    Sepsis ist eine mögliche Komplikation einer Infektion. Dabei werden Organe, die gar nicht von der Infektion betroffen waren, durch das eigene Immunsystem geschädigt. Dies kann lebensbedrohlich sein.
    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 14.1
    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
    - effect of interventions on 28-day total mortality
    - Prüfung des Einflusses der Interventionen auf die 28-Tage-Gesamtmortalität
    E.2.2Secondary objectives of the trial
    - effect of interventions on
    1. organ dysfunctions
    2. hospital and ICU length of stay / 90-day total mortality
    3. frequency and duration of mechanical ventilation
    4. frequency and duration of renal replacement therapy
    5. frequency and duration of therapy with vasopressors
    6. safety of the interventions
    7. 28-day total mortality and secondary objects 1 to 6 in the subgroup of patients, who survived at least 48 hours

    8. rapid eradication of infections by Procalcitonin
    9. duration, resistance and costs of antibitotic therapy by Procalcitonin
    - Evaluation der Auswirkung der Interventionen auf
    1. Organfunktionen
    2. ITS- und Krankenhausliegedauer / 90-Tage-Gesamtmortalität
    3. Mechanische Beatmung
    4. Nierenersatztherapie
    5. Therapie mit Vasopressoren
    6. Sicherheit der Interventionen
    7. Subgruppenanalyse aller Patienten, die min-destens 48 Stunden überleben (für primären End-punkt und sekundäre Endpunkte 1-6)

    8. Eradikation der zugrundeliegenden Infektion durch Procal-citonin-Steuerung
    9. Dauer, Resistenzen und Kosten der Antibiotikatherapie durch Procalcitonin-Steuerung
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - Effects of a procalcitonin guided causal therapy on survival of patients with severe sepsis and septic shock. Objective: To determine whether management of focus control and antimicrobial therapy by measurement of serum procalcitonin affects outcome of severe sepsis and septic shock (bifactorial design).
    - Continuation of the biomaterial bank for sever sepsis and septic shock. Objectives: Daily collection and storage of serum, plasma, and DNA samples
    - Einfluss einer Procalcitonin gesteuerten kausalen Therapie auf das Überleben von Patienten mit schwerer Sepsis / septischen Schock. Ziel: Untersuchung, ob die Steuerung der Fokussanierung und antimikrobiellen Therapie durch die Messung des Procalcitonins im Serum den Ausgang der schweren Sepsis / septischen Schock beeinflusst (bifaktorielles Design)
    - Fortführung der Biobank für schwere Sepsis / septischen Schock. Ziel: Tägliche Sammlung und Aufbewahrung von Serum-, Plasma- und DNA-Proben
    E.3Principal inclusion criteria
    1. Severe sepsis or septic shock
    2. Beginning of severe sepsis or of septic shock within the last 24 hours
    3. age >= 18 years
    4. Written informed consent of the patient or his court-appointed guardian or legal representative
    1. Schwere Sepsis oder septischer Schock
    2. Erkrankungsbeginn vor nicht mehr als 24 Stunden
    3. Alter >18 Jahre
    4. schriftliche Einwilligungserklärung des Patienten oder dessen gesetzlichen Vertreters oder Bevollmächtigten
    E.4Principal exclusion criteria
    1. Pregnant or nursing women
    2. women of child bearing potential without using a highly effective method of birth control. This is defined as those which result in a low failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed.
    3. Participation in other clinical trials within the last 30 days
    4. Current participation in any other scientific investigation or any other clinical trial
    5. Previous participation in this clinical trial
    6. Selenium intoxication
    7. Therapy restriction or adjustment (e.g. DNR - order)
    8. Bad prognosis due to accompanying disease(s)
    9. Close relationship to the trial physician (co-workers, relatives, colleagues)
    10. presence of infection, where guidelines recommend an antimicrobiological therapy for a longer time
    11. severely immunocompromised patients
    1. Frauen während der Schwangerschaft und Stillzeit,
    2. Fertile weibliche Patienten (< 2 Jahre nach der letzten Menstruation) ohne angemessene kontrazeptive Maß-nahmen (Implantate, Injektionen, orale Kontrazeptiva, in-trauterine devices – Spiralen etc., vasektomierter Part-ner) während der Teilnahme an der klinischen Prüfung (Studienteilnehmerinnen, die eine hormonelle Methode der Kontrazeption nutzen, müssen über mögliche Ein-flüsse der Prüfpräparate auf die Kontrazeption informiert werden)
    3. Teilnahme an einer klinischen Prüfung (Interventionsstu-die) innerhalb der letzten 30 Tage
    4. Aktuelle Teilnahme an einem anderen Forschungsprojekt oder einer anderen klinischen Prüfung
    5. Teilnahme des Patienten an dieser klinischen Prüfung zu einem früheren Zeitpunkt
    6. Selenintoxikation
    7. Therapiebeschränkung oder -einstellung (z.B. DNR-Order),
    8. Infauste Prognose aufgrund von Nebenerkrankungen
    9. Weitergehende Beziehung zum Prüfer (z.B. Mitarbeiter, Verwandte, Kollegen)
    10. Vorliegen einer Infektion, bei der Richtlinien eine längere antimikrobielle Therapie empfehlen
    11. schwer immunkompromittierte Patienten
    E.5 End points
    E.5.1Primary end point(s)
    28-day total mortality
    28 Tage Gesamtmortalität
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days after randomisation
    28 Tage nach Randomisation
    E.5.2Secondary end point(s)
    1. Mean total SOFA and SOFA subscores
    2. All cause mortality
    3. Frequency and duration of mechanical ventilation
    4. Frequency and duration of renal replacement therapy
    5. Frequency and duration of vasopressor support
    6. Frequency of adverse events and severe adverse events
    7. Clinical cure and microbiological cure
    8. Duration of antimicrobial therapy
    9. Costs of antimicrobial therapy
    10. Time to change of antibiotic therapy
    11. antibiotic exposure days
    12. Days alive without antimicrobial therapy
    13. Frequency of resistancies against antibiotics (VRE, MRSA, ESBL)
    14. ICU length of stay
    15. Hospital length of stay
    16. Rate of surgical procedures for focus control
    17. Rate of procedures to diagnose infections
    18. Frequency of new infections
    1. Mittlerer totaler SOFA-Score und SOFA-Subscores
    2. 90-Tage Gesamtmortalität
    3. Häufigkeit und Dauer einer mechanischen Beatmung bis Tag 90
    4. Häufigkeit und Dauer von Nierenersatzverfahren bis Tag 90
    5. Häufigkeit und Dauer einer Therapie mit Vasopressoren bis Tag 90
    6. Häufigkeiten von AEs und SAEs
    7. Clinical Cure und Microbiological Cure am Tag 4, 7, 10 und 14
    8. Dauer der Antibiotikatherapie
    9. Kosten der Antibiotikatherapie
    10. Dauer bis zur Änderung der Antibiotikatherapie
    11. Antibiotikaexposition
    12. Anzahl der Tage ohne Antibiotikatherapie
    13. Häufigkeit von Antibiotika – Resistenzen (VRE, MRSA, EBSL)
    14. ITS-Liegedauer bis Tag 90
    15. Krankenhausliegedauer bis Tag 90
    16. Anzahl chirurgischer (herdsanierender) Maßnahmen
    17. Anzahl diagnostischer Maßnahmen zur Fokussuche in-klusive nicht-routinemäßiger Maßnahmen
    18. Anzahl neuer Infektionen
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. ICU stay, maximal 21 days after randomisation
    2. - 5. 90 days after randomisation
    6. ICU stay, maximal 21 days after randomisation
    7. days 4, 7, 10, 14 after randomisation
    8. - 13. ICU stay, maximal 21 days after randomisation
    14. - 15. 90 days after randomisation
    16. - 18. ICU stay, maximal 21 days after randomisation
    1. über den gesamten Aufenthalt auf der Intensivstation, jedoch maximal bis Tag 21
    2. - 5. 90 Tage nach Randomisation
    6. über den gesamten Aufenthalt auf der Intensivstation, jedoch maximal bis Tag 21
    7. Tage 4, 7, 10 und 14 nach Randomsation
    8. - 13. über den gesamten Aufenthalt auf der Intensivstation, jedoch maximal bis Tag 21
    14. - 15. 90 Tage nach Randomisation
    16. - 18. über den gesamten Aufenthalt auf der Intensivstation, jedoch maximal bis Tag 21
    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 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) 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 No
    E.8.1.4Double blind Yes
    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 Yes
    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 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 concerned42
    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
    already provided in the protocol, see chapter 4.5
    im Prüfplan beschrieben, siehe Abschnitt 4.5
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    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.1.3Elderly (>=65 years) Yes
    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 2008-03-07. 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
    in general, patients are sedated and mechanically ventilated
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1180
    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)
    already provided in the protocol, see chapter 7.6.3
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation SepNet trials group
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-30
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