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    Clinical Trial Results:
    Daptomycin concentration in drainage fluid and blood samples of ICU patients

    Summary
    EudraCT number
    		 2015-000125-36
    Trial protocol
    		 DE  
    Global end of trial date
    31 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jun 2021
    First version publication date
    23 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Dapto
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03004066
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University hospital Tübingen
    Sponsor organisation address
    Hoppe-Seyler-Str. 3, Tübingen, Germany, 72076
    Public contact
    Intensive Care Unit 39, University Hospital Tübingen, +49 070712986724, helene.haeberle@med.uni-tuebingen.de
    Scientific contact
    Intensive Care Unit 39, University Hospital Tübingen, +49 070712986724, helene.haeberle@med.uni-tuebingen.de
    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
    Interim
    Date of interim/final analysis
    22 Sep 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Pharmakokinetics of Daptomycin in intensive care patients with wound drainage after surgery
    Protection of trial subjects
    all subjects received normal postoperative intensive care. No additional measures were necessary
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jul 2015
    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
    Germany: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    9
    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)
    7
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients receiving LVAD implantation for terminal heart failure

    Period 1
    Period 1 title
    baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    not blinded

    Arms
    Arm title
    		 Daptomycin
    Arm description
    		 All patients received Daptomycin after LVAD implantation according to our internal standards.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daptomycin
    Investigational medicinal product code
    J01XX09
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    6mg/kg per day, intravenous infusion

    Number of subjects in period 1
    		Daptomycin
    Started
    9
    Completed
    9

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Daptomycin
    Reporting group description
    		 All patients received Daptomycin after LVAD implantation according to our internal standards.

    Subject analysis set title
    blood concentrations
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all patients included into the trial

    Subject analysis set title
    drain fluid concentrations
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all patients included into the trial

    Primary: concentrations

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    End point title
    		 concentrations [1]
    End point description
    End point type
    Primary
    End point timeframe
    day 1 to 3
    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 trial was designed as a pilot project to determine whether a trial including more subjects could be done and should be planned. only 9 subjects were included into the trial.
    End point values
    		 Daptomycin blood concentrations drain fluid concentrations
    Number of subjects analysed
    9
    9
    9
    Units: mg/l
        arithmetic mean (standard deviation)
    30.2 ( 10.2 )
    50.8 ( 14.7 )
    19.9 ( 8.0 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    3 days
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: within the monitored time period no adverse events where reported.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Feb 2018
    trial timeline was changed from 01.07.2016-01.07.2018 to 01.07.2016-31.03.2019 (end of trial)

    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.
    this small trial included patients with terminal heart disease in need of a LVAD implantation and receiving Daptomycin for 3 days, which is a very small collective to recruit from.
    For support, Contact us.
    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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