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    Summary
    EudraCT Number:2014-003468-19
    Sponsor's Protocol Code Number:NL50040.029.14
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-01-08
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-003468-19
    A.3Full title of the trial
    The effects of hyperoxia on organ dysfunction and outcome in critically ill patients with SIRS
    Het effect van hyperoxie op orgaan dysfunctie en overleving in Intensive Care patienten met SIRS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of increased oxygen levels on organ failure and survival in critically ill patients with systemic inflammation
    Het effect van verhoogde zuurstofwaarden op orgaanfalen en overleving bij Intensive Care patienten met een systemische ontstekingsreactie
    A.3.2Name or abbreviated title of the trial where available
    Hyperoxia and SIRS
    Hyperoxie en SIRS
    A.4.1Sponsor's protocol code numberNL50040.029.14
    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 SponsorVU University Medical Center
    B.1.3.4CountryNetherlands
    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 supportZonMW
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU University Medical Hospital
    B.5.2Functional name of contact pointDepartment of Intensive Care
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31204443697
    B.5.6E-mailam.spoelstra@vumc.nl
    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 Conoxia
    D.2.1.1.2Name of the Marketing Authorisation holderLinde Healthcare Benelux
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameConoxia
    D.3.4Pharmaceutical form Gas and solvent for dispersion for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXYGEN
    D.3.9.3Other descriptive nameConoxia
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number100
    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
    Intensive Care patients with the systemic inflammatory response syndrome
    Intensive Care patienten met een systemisch inflammatoir response syndroom
    E.1.1.1Medical condition in easily understood language
    Intensive Care patients with a systemic inflammation
    Intensive Care patienten met een systemische ontstekingsreactie
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10062357
    E.1.2Term SIRS
    E.1.2System Organ Class 100000004867
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the short- and long-term effect of different PaO2 targets on circulatory status, organ dysfunction and outcome.
    Het onderzoeken van de korte en lange termijn effecten van verschillende streef zuurstofwaarden op circulatie, orgaan dysfunctie en overleving.
    E.2.2Secondary objectives of the trial
    To study underlying mechanisms of hyperoxia by determining differences in oxidative stress response between the hyperoxic patients and the normoxemic groups.
    Het onderzoeken van e onderliggende mechanismen van hyperoxie door het bepalen van verschillen in oxidatieve stress tussen patienten met hyperoxie en normoxie.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    To further investigate the circulatory changes due to differences in oxygen suppletion, we will study additional parameters in a subgroup of 40 patients, which are too time-consuming to be performed in the whole group. We will estimate hemodynamics by PICCO (C.I., SVRI, extravascular lung water), microcirculation by sublingual Sidestream Dark Field imaging, and body fluid status by bio-impedance.
    In 40 patienten zullen we de circulatie intensiever onderzoeken (deze onderzoeken zijn te tijdrovend om bij de gehele groep te doen):
    -hemodynamiek door PICCO (C.I., SVRI, extravasculair long water),
    -microcirculatie met sublinguale Sidestream Dark Field imaging
    -vochtbalans met bio-impedantie.
    E.3Principal inclusion criteria
    -Age ≥18 years
    -≥2 positive SIRS-criteria:
    Temperature >38oC or hypothermia <36oC
    Heart rate >90 bpm
    Respiratory rate >20 /min or pCO2 <32 mmHg (4.3 kPa)
    Number of leucocytes >12 x 109/l of <4 x 109/l of >10% bands
    -Within 12 hours of admittance to the ICU
    -Expected stay of more than 48 hours as estimated by the attending physician
    -Leeftijd ≥18 jaar
    -≥2 positieve SIRS-criteria:
    Temperatuur >38oC of hypothermie <36oC
    Hart frequentie >90 bpm
    Ademhalingsfrequentie >20 /min of pCO2 <32 mmHg (4.3 kPa)
    Aantal leucocyten >12 x 109/l of <4 x 109/l of >10% staven
    -Binnen 12 uur van opname op de IC
    -Verwachte verblijfsduur van > 48 uur zoals ingeschat door de behandelend arts
    E.4Principal exclusion criteria
    -Elective surgery
    -Carbon monoxide poisoning
    -Cyanide intoxication
    -Methemoglobinemia
    -Pregnancy
    -Severe COPD (Gold class III or IV) or other sever chronic pulmonary disease
    -Sickle cell anemia
    -Known pulmonary arterial hypertension (WHO class III or IV)
    -Known cardiac right to left shunting
    -Electieve chirurgie
    -Koolmonoxide vergiftiging
    -Cyanide intoxicatie
    -Methemoglobinemie
    -Zwangerschap
    -Ernstige COPD (Gold class III of IV) of andere ernstig chronisch longlijden
    -Sikkelcelanemie
    -Pulmonale arteriele hypertensie (WHO klasse III of IV)
    -Cardiale rechts-links shunting
    E.5 End points
    E.5.1Primary end point(s)
    The cumulative Δ Sequential Organ Failure (SOFA) score within the first 14 days of inclusion
    De cumulatieve Δ Sequential Organ Failure (SOFA) score gedurende de eerste 14 dagen
    E.5.1.1Timepoint(s) of evaluation of this end point
    First 14 days
    Eerste 14 dagen
    E.5.2Secondary end point(s)
    Secondary parameters will include time spent in the assigned PaO2 range, hypoxic episodes (PaO2 <55 mmHg), vasopressor / inotrope requirements (max dose every 24 hours), need for renal replacement therapy and fluid balances (every 24 hours). Furthermore, oxidative stress parameters F2-isoprostanes will be determined (on day 1, 2 and 4) and as clinical endpoints: duration of mechanical ventilation, lung injury score, ventilator-free days, length of stay (in ICU, in hospital) and mortality (ICU and hospital).
    Secondaire parameters: tijd binnen streef PaO2 bereik, hypoxische episodes (PaO2 <55 mmHg), vasopressor / inotropie behoeften (max dosis elke 24 uur), noodzaak tot nierfunctievervangende therapie, vochtbalans (elke 24 uur). Oxidatieve stress parameters F2-isoprostanes op dag 1, 2 en 4) en als klinische eindpunten: duur beademing, lung injury score, ventilator-vrije dagen, ligduur IC en in ziekenhuis, mortaliteit (IC en ziekenhuis).
    E.5.2.1Timepoint(s) of evaluation of this end point
    First 14 days
    Eerste 14 dagen
    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 No
    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) 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 Yes
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Andere streefwaarde van PaO2
    Other target range of PaO2
    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 concerned3
    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
    Nadat 400 patienten geincludeerd zijn
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 2015-01-08. 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
    The included patients are staying at the Intensive Care and therefore unable to give consent personally
    De patienten zijn opgenomen op de Intensive Care en daarom niet in staat zelf toestemming te geven
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state400
    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)
    The oxygen target only applies during their stay at the ICU. At the ward the patients are treated according to standard care.
    De zuurstof streefwaarden worden alleen aangehouden gedurende het verblijf op de Intensive Care. Na overplaatsing naar de verpleegafdeling wordt er weer overgegaan op standaard behandeling
    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 Decision2015-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-29
    P. End of Trial
    P.End of Trial StatusOngoing
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