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    Clinical Trial Results:
    PHARMACOKINETICS OF MICAFUNGIN DURING CONTINUOUS VENOVENOUS HEMOFILTRATION

    Summary
    EudraCT number
    		 2012-000904-14
    Trial protocol
    		 AT  
    Global end of trial date
    01 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 May 2020
    First version publication date
    29 May 2020
    Other versions
    Summary report(s)
    		 Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    MICA_HDF
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Florian Thalhammer, Medizinische Universität Wien, 0043 14040044400, florian.thalhammer@meduniwien.ac.at
    Scientific contact
    Florian Thalhammer, Medizinische Universität Wien, 0043 14040044400, florian.thalhammer@meduniwien.ac.at
    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
    12 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Measuring pharmakokinetecs of micafungin during continuous renal replacement therapy
    Protection of trial subjects
    None necessary (PK sampling using HF machine ports only)
    Background therapy
    		 none
    Evidence for comparator
    		 no comparator
    Actual start date of recruitment
    27 Jul 2012
    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
    Austria: 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)
    9
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment started End of June 2013 and concluded December 2014. Patients from all ICUs of the general hospital of vienna were included.

    Pre-assignment
    Screening details
    		 Patients receiving Micafungin and high-flow CVVHDF or CVVHD during their ICU stay were screened.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    none

    Arms
    Arm title
    		 Micafungin therapy
    Arm description
    		 PK Parameters from Patients receiving Micafungin were evaluated
    Arm type
    		 Experimental

    Investigational medicinal product name
    Micafungin
    Investigational medicinal product code
    J02AX05
    Other name
    Mycamine
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    1x100mg

    Number of subjects in period 1
    		Micafungin therapy
    Started
    10
    Completed
    7
    Not completed
    3
         Adverse event, serious fatal
    1
         Physician decision
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 10 10
    Age categorical
    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
    		 0
        85 years and over
    		 0
    Age continuous
    56.6 ± 11.4
    Units: years
        geometric mean (standard deviation)
    		 56.6 ± 11.4 -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 7 7

    End points

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    End points reporting groups
    Reporting group title
    Micafungin therapy
    Reporting group description
    		 PK Parameters from Patients receiving Micafungin were evaluated

    Primary: Clearance

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    End point title
    		 Clearance [1]
    End point description
    Pre-/post Hemofilter Clearance
    End point type
    Primary
    End point timeframe
    48 hours
    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: Purely descriptive pharmacokinetic trial, no statistic calculations were performed
    End point values
    		 Micafungin therapy
    Number of subjects analysed
    7
    Units: ml/min
    arithmetic mean (standard deviation)
        clearance
    46.0 ± 21.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    48 hours
    Adverse event reporting additional description
    Adverse events were assessed by chart review
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    whole trial
    Reporting group description
    		 all subjects

    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: No Adverse events apart from the two documented SAEs have been found
    Serious adverse events
    		 whole trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 10 (20.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Vascular disorders
    Haemorrhage
    Additional description: The pre-existing leak of the aorta worsened in the earla morning of the 1st of April 2014. As a result the patient had to undergo emergency surgery. The bleeding was found to originate from under a aortal stent and was linked to leaking intraabdomi
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Death
    Additional description: Patient was septic when Mycamine treatment was initiated. She did not respond to treatment and her condition deteriorated dramatically. On the 20th of February 2014 the Pt. died. In the post-mortem analysis a toxic megacolon was found
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 whole trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jun 2014
    Additional sampling at hour 1, 25 and 49

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28584142
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