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    Clinical Trial Results:
    Hyperbaric oxygen treatment in humans with Gram Positive Cocci endocarditis

    Summary
    EudraCT number
    		 2019-000857-29
    Trial protocol
    		 DK  
    Global end of trial date
    30 Jun 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Oct 2023
    First version publication date
    15 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ENDOHOT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04691440
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Inge Lehmanns Vej 6, section 6011, Copenhagen N, Denmark, 2100
    Public contact
    Hyperbaric Unit sect.4092, Rigshospitalet - University Hospital of Copenhagen, ole.hyldegaard@regionh.dk
    Scientific contact
    Hyperbaric Unit sect.4092, Rigshospitalet - University Hospital of Copenhagen, 45 35454092, ole.hyldegaard@regionh.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Oct 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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.
    Protection of trial subjects
    Feasability study, phaze II. Ethical approval, GCP monitoring and reporting to the Danish Medicines Agency.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 26 patients screened for inclusion diagnosed with endocarditis - gram positive cocci endocarditis. Of these 13 patients were excluded. 13 patients where enrolled into the HBOT protocol.

    Pre-assignment
    Screening details
    		 13 patients out of 26 screened excluded.

    Period 1
    Period 1 title
    2019-2022 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 HBOT
    Arm description
    		 Adjuvant HBOT for endocarditis
    Arm type
    		 Experimental

    Investigational medicinal product name
    Conoxia
    Investigational medicinal product code
    23390
    Other name
    oxygen
    Pharmaceutical forms
    Pressurised inhalation
    Routes of administration
    Respiratory use
    Dosage and administration details
    Hyperbaric oxygen. Delivered as inspiratory oxygen fraction of 1.0 at 245 kPa (- or 2.4 ATA, atmospheres absolute pressure) for 90 minutes.

    Number of subjects in period 1
    		HBOT
    Started
    10
    Completed
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    2019-2022
    Reporting group description
    		 -

    Reporting group values
    		 2019-2022 Total
    Number of subjects
    		 10 10
    Age categorical
    Patients with confirmed gram possitive endocarditis and > 18 years of age
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 10 10
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 80 (73.2 to 82.8) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 7 7
    Subject analysis sets

    Subject analysis set title
    Patient compliance
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patient compliance

    Subject analysis sets values
    		 Patient compliance
    Number of subjects
    10
    Age categorical
    Patients with confirmed gram possitive endocarditis and > 18 years of age
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    10
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    80 (73.2 to 82.8)
    Gender categorical
    Units: Subjects
        Female
    3
        Male
    7

    End points

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    End points reporting groups
    Reporting group title
    HBOT
    Reporting group description
    		 Adjuvant HBOT for endocarditis

    Subject analysis set title
    Patient compliance
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patient compliance

    Primary: Patient compliance

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    End point title
    		 Patient compliance [1]
    End point description
    End point type
    Primary
    End point timeframe
    2019-2022
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This is a feasibility study (phase II trial) where testing the practical adjuvant use of HBOT in patients with endocarditis is the primary focus. Sub-group analysis will provide statistiacal comparisons on patients paraclinical data before and after the intervention.
    End point values
    		 HBOT Patient compliance
    Number of subjects analysed
    10
    10
    Units: number of treatments
        number (not applicable)
    10
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Non-serious AEs will be collected in the present study only during the HBOT-period. serious AEs is collected, registered in the CRFs and an assessment of causality performed.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 GCP monitor
    Dictionary version
    1
    Reporting groups
    Reporting group title
    ENDOHOT trial
    Reporting group description
    		 -

    Serious adverse events
    		 ENDOHOT trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ENDOHOT trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 10 (20.00%)
    Psychiatric disorders
    Claustrophobia
         subjects affected / exposed
    2 / 10 (20.00%)
         occurrences all number
    13

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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