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    Clinical Trial Results:
    Pharmacokinetics of micafungin (Mycamin ®) as antifungal prophylaxis given twice weekly intravenously compared to micafungin given daily to patients at risk for developing an invasive fungal disease.

    Summary
    EudraCT number
    		 2013-002848-93
    Trial protocol
    		 NL   BE  
    Global end of trial date
    30 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Oct 2020
    First version publication date
    04 Oct 2020
    Other versions
    Summary report(s)
    		 MATADOR paper

    Trial information

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    Trial identification
    Sponsor protocol code
    UMCN-AKF13.02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboudumc
    Sponsor organisation address
    Geert Grooteplein 10, Nijmegen, Netherlands,
    Public contact
    Roger Brüggemann, Radboud University Medical Centre, +31 243616405, roger.bruggemann@radboudumc.nl
    Scientific contact
    Roger Brüggemann, Radboud University Medical Centre, +31 243616405, roger.bruggemann@radboudumc.nl
    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
    21 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    30 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To determine the pharmacokinetics of micafungin 300 mg given twice weekly on Mondays and Thursdays in patients at risk for developing an invasive fungal disease (patients who are being treated for acute or chronic graft versus host disease; patients receiving reduced intensity conditioning for SCT; receiving first remission induction chemotherapy for AML/MDS) compared to the pharmacokinetics of micafungin 100 mg given daily to the same population.
    Protection of trial subjects
    The risk-classification is assessed as negligible to the patient population receiving study drug at the current regimens. The drug is licensed for the use investigated in this protocol. Safety data on the use of higher dose are published and very-well defined. There is no attributable risk for the application of the study protocol to the haematology patients at risk for fungal infections.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Dec 2013
    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
    Netherlands: 9
    Country: Number of subjects enrolled
    Belgium: 11
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    18
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 recruitment in IC.

    Pre-assignment
    Screening details
    		 The included patientswere receiving immunosuppressive therapy for acute graft-versus-host disease (aGVHD) grade II–IV, undergoing reducedintensity conditioning regimens for allogeneic HSCT, or receiving first remission-induction chemotherapy for AML/myelodysplastic syndrome (MDS), who were at least 18years of age, if female were not pregnant.

    Pre-assignment period milestones
    Number of subjects started
    		 20
    Number of subjects completed
    		 20

    Period 1
    Period 1 title
    screening
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    not applicable

    Arms
    Arm title
    		 screening
    Arm description
    		 screening
    Arm type
    		 no intervention

    Investigational medicinal product name
    micafungin screening
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    in the screening period no micafungin was given

    Number of subjects in period 1
    		screening
    Started
    20
    Completed
    20
    Period 2
    Period 2 title
    900 mg mica
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    not applicable

    Arms
    Arm title
    		 mica 900mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    micafungin 900mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    300mg of micafungin twice weekly for 8 days (Group A, receiving 900mg in total

    Number of subjects in period 2
    		mica 900mg
    Started
    20
    Completed
    20
    Period 3
    Period 3 title
    mica 800mg
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    not applicable

    Arms
    Arm title
    		 mica 800mg
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    micafungin 800mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100mg of micafungin once daily for 8 days

    Number of subjects in period 3
    		mica 800mg
    Started
    20
    Completed
    19
    Not completed
    1
         CVC removed
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    screening
    Reporting group description
    		 -

    Reporting group values
    		 screening Total
    Number of subjects
    		 20 20
    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
    Units: years
        median (full range (min-max))
    		 59.5 (36 to 68) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 12 12

    End points

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    End points reporting groups
    Reporting group title
    screening
    Reporting group description
    		 screening
    Reporting group title
    mica 900mg
    Reporting group description
    		 -
    Reporting group title
    mica 800mg
    Reporting group description
    		 -

    Primary: area under the curve

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    End point title
    		 area under the curve [1]
    End point description
    End point type
    Primary
    End point timeframe
    0-168 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: no statistical test was done to compare, only descriptive
    End point values
    		 mica 900mg mica 800mg
    Number of subjects analysed
    20
    19
    Units: mg*h/L
        median (inter-quartile range (Q1-Q3))
    690 (538 to 829)
    596 (485 to 717)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    entire study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    1
    Reporting groups
    Reporting group title
    entire group
    Reporting group description
    		 -

    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: none reported
    Serious adverse events
    		 entire group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 20 (30.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Blood and lymphatic system disorders
    CVC-ralted thrombosis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    neutropenic enterocolitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    respiratory insufficiency
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    pulmonary rhizomucor infection
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    renal insufficiency
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    painfull arthritis wrist
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Eppstein Barr virus reactivation
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 entire group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30137340
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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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