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    Summary
    EudraCT Number:2013-003556-20
    Sponsor's Protocol Code Number:RH4131-03
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-02-12
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2013-003556-20
    A.3Full title of the trial
    Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial
    Behandling af patienter med nekrotiserende bløddelsinfektioner med intravenøs, polyspecifik immunoglobulin G
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunoglobulin for Necrotizing Soft Tissue Infections
    Behandling af nekrotiserende bløddelsinfektioner med immunoglobulin
    A.3.2Name or abbreviated title of the trial where available
    INSTINCT
    A.4.1Sponsor's protocol code numberRH4131-03
    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 SponsorDept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet
    B.1.3.4CountryDenmark
    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 supportDept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet
    B.5.2Functional name of contact pointForskningskontoret
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number004535454131
    B.5.5Fax number004535452736
    B.5.6E-mailmartin.bruun.madsen.01@regionh.dk
    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 Privigen 100 mg/ml solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderCSL Behring GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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 INNHuman normal immunoglobulin (IVIg)
    D.3.9.1CAS number 308067-58-5
    D.3.9.3Other descriptive nameIMMUNOGLOBULIN G
    D.3.9.4EV Substance CodeSUB20618
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    D.3.11.7Plasma derived medicinal product Yes
    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
    Necrotizing Soft Tissue Infections
    Nekrotiserende bløddelsinfektioner
    E.1.1.1Medical condition in easily understood language
    Infections of the skin, subcutis, fat and/or muscle with necrosis
    Infektioner i hud, underhud, fedt- og/eller muskelvæv med nekrose
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10055648
    E.1.2Term Necrotizing fasciitis fungal
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10052892
    E.1.2Term Necrotising fasciitis fungal
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10055647
    E.1.2Term Necrotizing fasciitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10055649
    E.1.2Term Necrotizing fasciitis staphylococcal
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10017068
    E.1.2Term Fournier's gangrene
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10028885
    E.1.2Term Necrotising fasciitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10016229
    E.1.2Term Fasciitis necrotising
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10028886
    E.1.2Term Necrotising fasciitis NOS
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10028888
    E.1.2Term Necrotising fasciitis streptococcal
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10028887
    E.1.2Term Necrotising fasciitis staphylococcal
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10055650
    E.1.2Term Necrotizing fasciitis streptococcal
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10055643
    E.1.2Term Fasciitis necrotizing
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate the effect of intravenous, polyspecific immunoglobulin G compared with placebo on the patient reported outcome measure Physical Component Summary Score (PCS) of the Short Form-36 (SF-36) in patients with necrotizing soft tissue infections.
    At estimere effekten af intravenøs, polyspecifik immunoglobulin G, sammenlignet med placebo, på det patient rapporterede outcome "Physical Component Summary Score" (PCS) fra Short Form-36 (SF-36) på patienter med nekrotiserende bløddelsinfektioner.
    E.2.2Secondary objectives of the trial
    To estimate the frequency of serious adverse reactions for intravenous, polyspecific immunoglobulin G in patients with necrotizing soft tisse infections.
    At estimere antallet af alvorlige bivirkninger ved brug af intravenøs, polyspecifik immunoglobulin G til patienter med nekrotiserende bløddelsinfektioner.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Necrotizing soft tissue infection based on surgical findings
    Age >=18 years
    Admitted to or planned to be admitted to the ICU at Copenhagen University Hospital, Rigshospitalet
    Nekrotiserende bløddelsinfektion, baseret på de kirurgiske fund
    Alder >= 18 år
    Indlagt eller planlagt indlagt på ITA, Rigshospitalet
    E.4Principal exclusion criteria
    • >48 hour from the primary diagnosis to arrival at Copenhagen University Hospital, Rigshospitalet
    • More than one dose of intavenous, polyspecific immunoglobulin G (IVIG) given within current admission
    • Known hypersensitivity to IVIG
    • Hyperprolinaemia
    • Pregnancy or breast feeding
    • >48 fra primære diagnose til ankomst på Rigshoapitalet
    • Mere end én dosis intravenøs, polyspecifikt immunoglobulin G (IVIG) givet i forbindelse med denne indlæggelse
    • Kendt hypersensibilitet til IVIG
    • Hyperprolinæmia
    • Gravid eller ammende
    E.5 End points
    E.5.1Primary end point(s)
    Physical Component Summary Score (PCS) of Short Form-36 (SF-36)
    Physical Component Summary Score (PCS) fra Short Form-36 (SF-36)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Six months after randomisation
    Seks måneder efter randomisering
    E.5.2Secondary end point(s)
    Mortality at 28, 90 and 180 days
    Time to resolution of shock
    Severe bleeding as clinical bleeding and use of 3 units of RBCs within 24 hours at any time in the ICU
    Any bleeding in the ICU
    Use of blood products (total volumes during the ICU admission)
    SOFA scores days 1-7 (AUC), excluding the GCS score
    Use of RRT, ventilation and vasopressor in the ICU
    Days alive off life support in the 90 days after randomisation
    Days alive and out of hospital in the 180 day follow-up period
    Amputation, any location, within 180 days
    SARs in the ICU (allergic reactions, haemolytic anaemia, aseptic meningitis syndrome, thrombi, transmittable agents and acute kidney injury as noted in the SPC for Privigen)
    Mortalitet efter 28, 90 og 180 dage
    Tid til patienten ikke længere er i shock
    Svær blødning sv.t. klinisk blødning og brug af 3 enheder RBC inden for 24 timer på ITA
    Enhver blødning på ITA
    Forbrug af blodprodukter (toal volumen under ITA indlæggelse)
    SOFA scores dag 1-7 (AUC), uden GCS
    Brug af dialyse, ventilation og vasopressor på ITA
    Dage i live og uden "life support" i 90 dage efter randomisering
    Dage i live og uden for hospital i opfølgningsperioden (180 dage)
    Amputationsgrad, enhver lokalisation, indenfor 180 dage
    SARs på ITA (allergiske reaktioner, hæmolytisk anæmi, aseptisk meningitis syndrom, thrombi, overførbare agens og akut nyresvigt, som beskrevet i SPC for Privigen)
    E.5.2.1Timepoint(s) of evaluation of this end point
    28, 90 and 180 days (mortality)
    Varying (time to resolution of shock)
    In the ICU (severe bleeding as clinical bleeding and use of 3 units of RBCs within 24 hours)
    In the ICU (any bleeding in the ICU)
    In the ICU (use of blood products (total volumes during the ICU admission))
    Day 1-7 (SOFA scores (AUC), excluding the GCS score)
    In the ICU (use of RRT, ventilation and vasopressor)
    Day 1-90 (days alive off life support)
    Day 1-180 (days alive and out of hospital)
    Day 1-180 (need for amputation)
    In the ICU (SARs)
    28, 90 og 180 dage (mortalitet)
    Varierende (tid til patienten ikke længere er i shock)
    På ITA (svær blødning sv.t. klinisk blødning og brug af 3 enheder RBC inden for 24 timer)
    På ITA (enhver blødning på ITA)
    På ITA (forbrug af blodprodukter (toal volumen under ITA indlæggelse))
    Dag 1-7 (SOFA scores (AUC), uden GCS)
    På ITA (brug af dialyse, ventilation og vasopressor)
    Dag 1-90 (dage i live og uden "life support")
    Dag 1-180 (dage i live og uden for hospital)
    Dag 1-180 (amputationsgrad)
    På ITA (SARs)
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 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.8.6 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
    LVLS
    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 months0
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 2014-02-12. 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
    The majority of patients considered to be included in the trial will be temporarily incompetent because of severe illness or as a consequence of the treatment (sedation).
    Hovedparten af patienterne vil være midlertidigt inhabile, enten grundet den svære sygdom, eller grundet behandlingen (sedation).
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 100
    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
    Ingen
    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 Decision2014-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-07
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