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    Summary
    EudraCT Number:2019-000857-29
    Sponsor's Protocol Code Number:ENDOHOT
    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:2019-03-14
    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 number2019-000857-29
    A.3Full title of the trial
    Hyperbaric oxygen treatment in humans with Gram Positive Cocci endocarditis
    Hyperbar Iltbehandling til patienter med gram positiv endokarditis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hyperbaric oxygen therapy for patients with bacterial infection of the inner lining of the heart and valves
    Hyperbar Iltbehandling til patienter med bakteriel infektion af hjertes indre væg og hjerteklapper
    A.4.1Sponsor's protocol code numberENDOHOT
    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 SponsorRigshospitalet - University Hospital of Copenhagen
    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 supportRigshospitalet - University Hospital of Copenhagen
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet - University Hospital of Copenhagen
    B.5.2Functional name of contact pointHyperbaric Unit sect.4092
    B.5.3 Address:
    B.5.3.1Street AddressJuliane Maries Vej 8
    B.5.3.2Town/ cityCopenhagen Ø
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.6E-mailole.hyldegaard@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 Conoxia 100%
    D.2.1.1.2Name of the Marketing Authorisation holderAGA AB
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bacterial Endocarditis
    Bakteriel endokardit
    E.1.1.1Medical condition in easily understood language
    Treatment of bacterial infection of the inner lining of the heart and valves using hyperbaric oxygen therapy.
    Behandling af bakteriel infektion af hjertets indre overflade og klapper ved brug af hyperbar oxygen behandling.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10057480
    E.1.2Term Hyperbaric oxygen therapy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess feasibility including patient compliance of adding HyperBaric Oxygen Treatment (HBOT) to the standard management of patients with proven bacterial endocarditis.
    At vurdere gennemførligheden for adjuverende hyperbar iltbehandling til patienter med bakteriel endokardit.
    E.2.2Secondary objectives of the trial
    Not applicable
    Ikke relevant
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Left sided IE with gram positive cocci.
    2) IE has been diagnosed according to modified Duke Criteria.
    3) Patients must be stable, by means of no need for hemodynamic pressure support.
    4) The patient must be able to be seated for the 1.5 hour the HBOT at least two times a day for 3 days.
    5) The patient must be able to perform Valsalva’s – or Frenzels manoeuvre – to equalize middle ear pressure. As prophylaxis, all patients will receive detumescent nose drops as Otrivin® to facilitate ear- and sinuses equilibration. In the rare event it is still not possible for the patient to equalize pressure, a paracentesis or drainage of the tympanic membrane must be performed by the ENT doctor. All according to daily practice.
    6) The upstart of HBOT must be within the first week of relevant antibiotic IE therapy.
    7) If a central venous catheter has been inserted, a chest X-ray must confirm no suspicion of pneumothorax.
    8) Patients must be >18-years old.
    1) Venstre sidet IE med gram positive cocci.
    2) IE er blevet diagnosticeret i henhold til Duke Criteria.
    3) Patienterne skal være stabile, uden behov for hæmodynamisk inotropi støtte.
    4) Patienten skal kunne sidde i 1,5 time HBOT mindst to gange om dagen i 3 dage.
    5) Patienten skal kunne udføre Valsalvas - eller Frenzels manøvre - for at udligne trykket i mellemøret. Som profylakse vil alle patienter modtage detumecerende næsedråber som Otrivin® for at lette øre- og bihule trykudligning. I sjældne tilfælde hvor det ikke er muligt for patienten at udligne trykket, udføres en paracentese eller dræning af tympanisk membrana tymp. ved ØNH-læge.
    6) Opstart af HBOT skal være inden for den første uge af relevant antibiotisk IE-terapi.
    7) Hvis et centralt venøst kateter er blevet indsat, skal røntgen af thorax udelukke pneumothorax.
    8) Patienterne skal være> 18 år gamle.
    E.4Principal exclusion criteria
    1) Claustrophobia that cannot be reversed by mild sedatives.
    2) Patients requiring mechanical ventilation.
    3) Undrained pneumothorax
    4) Pregnancy
    5) Unable to follow and understand simple commands
    6) Non-compliant
    1) Claustrofobi, der ikke kan reverseres af milde sedativer.
    2) Patienter, der kræver mekanisk ventilation.
    3) Udræneret pneumothorax
    4) Graviditet
    5) Hvis ikke kan følge og forstå enkle kommandoer og instrukser
    6) Manglende kompliance
    E.5 End points
    E.5.1Primary end point(s)
    Observations of interest / endpoints:
    1) Patient baseline data
    2) Patient compliance (tolerance/acceptance of the treatment – and number of the scheduled 6 treatments accepted by the patients)
    3) Practical feasibility (are we capable of organising all 6 treatments for the individual patients according to the protocol)
    4) Findings at echocardiography (TTE/TEE) within 48 h before HBOT and < 48 h after last HBOT
    5) Daily blood samples with infection parameters: CRP, PCT, leukocyte + differential count, Hb
    6) One blood sample for Biomarkers (10mL EDTA)
    7) Blood cultures of patients daily
    8) Blood sample for Dihydrorhodamin testing (DHR, functionality of the PMNs respiratory burst capacity) and fagocytosis test less than one hour before the first daily HBOT and right after. Likewise, for the coagulation status by means of TEG/rotem analysis.
    Observationer af interesse / slutpunkter:
    1) Patientbaseline data
    2) Patient kompliance (tolerance / accept af behandlingen - og antal af de planlagte 6 behandlinger accepteret af patienterne)
    3) Praktisk gennemførlighed (kan vi organisere alle 6 behandlinger for de enkelte patienter i henhold til protokollen)
    4) Resultater ved ekkokardiografi (TTE / TEE) inden for 48 timer før HBOT og <48 timer efter sidste HBOT
    5) Daglige blodprøver med infektionsparametre: CRP, PCT, leukocyt + differentialtælling, Hb
    6) En blodprøve til biomarkører (10 ml EDTA)
    7) Blodkulturer af patienter dagligt
    8) Blodprøve til Dihydrorhodamin-testning (DHR, funktionalitet af PMNs respiratorisk udbrydningskapacitet) og fagocytose test mindre end en time før den første daglige HBOT og lige efter. På samme måde for koagulationsstatus ved hjælp af TEG / rotem analyse.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patient endpoints at minimum 48 hours after last HBOT session during hospitalization and until discharge.
    Patient udkomme ved minimum 48 timer efter sidste HBOT session under hospitalisering og indtil udskrivning.
    E.5.2Secondary end point(s)
    Not applicable.
    Ikke relevant.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable.
    Ikke relevant.
    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 No
    E.6.4Safety Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    This is a feasibility study.
    Dette er et gennemførligheds- og patient kompliance studie.
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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 No
    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
    Last patient last visit (LVLS).
    Sidste patients sidste besøg (LVLS).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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)
    Patients will recieve continued standard of care after the intervention of hyperbaric oxygen which is considered adjuvant therapy.
    Patienterne vil modtage fortsat standard behandling efter intervention med hyperbar oxygen behandling som er adjuverende behandling til standard.
    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 Decision2019-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-30
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