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    Clinical Trial Results:
    Pharmacokinetics of vancomycin in cancellous and cortical bone obtained by microdialysis

    Summary
    EudraCT number
    		 2014-000258-12
    Trial protocol
    		 DK  
    Global end of trial date
    29 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Mar 2017
    First version publication date
    03 Mar 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    230189
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ortopædkirurgisk afdeling, Aarhus Universitetshospital
    Sponsor organisation address
    Tage Hansens Gade 2, Aarhus C, Denmark, 8000
    Public contact
    Mats Bue, Hospital Unit Horsens, 25599294 25599294, matsbue@hotmail.com
    Scientific contact
    Mats Bue, Hospital Unit Horsens, 25599294 25599294, matsbue@hotmail.com
    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
    29 Apr 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jan 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this trial is to asses the penetration of vancomycin into bone tissue using the pharmacokinetic tool microdialysis. The primary endpoint is the area under the concentration-time curve (AUC) above the MIC (minimal inhibitory concentration) for staphylococcus aureus. Secondary endpoints are standard pharmacokinetic parameters.
    Protection of trial subjects
    Measures to trial subjects a good experience with clinical trials.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2014
    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
    		 -

    Pre-assignment
    Screening details
    		 - The patients must be scheduled for a knee prosthesis. The indication must be arthrosis. - Normal kindey function. Serum creatnine must be within the range of 60-100 umol/l. - Male gender. - The patiens must be competent Exclusion criteria: Allergic to vancomycin or cefuroxime, ongoing treatment with vancomycin, female gender

    Pre-assignment period milestones
    Number of subjects started
    		 10
    Number of subjects completed
    		 10

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

    Arms
    Arm title
    		 Overall trial
    Arm description
    		 All subjects recieved the same amount of drug. No randomisation.
    Arm type
    		 All subjects recieved the same amount of drug

    Investigational medicinal product name
    Vancomycin "Hospira"
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000 mg milligram(s) administered over 100 min

    Number of subjects in period 1
    		Overall trial
    Started
    10
    Completed
    10

    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 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
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 10 10

    End points

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    End points reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 All subjects recieved the same amount of drug. No randomisation.

    Primary: Time to MIC 1

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    End point title
    		 Time to MIC 1 [1]
    End point description
    Time (min) to mean concentrations of 1 for plasma, subcutaneous adipose tissue and cancellous and cortical bone (MICs).
    End point type
    Primary
    End point timeframe
    From 0 to 8 hours of sampling
    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: By use of Microsoft Excel, the time to mean MICs of 1, 2, 4 and 8 mg/L was estimated using linear interpolation
    End point values
    		 Overall trial
    Number of subjects analysed
    10
    Units: Time (min)
        Plasma
    1
        Subcutaneous adipose tissue
    20
        Cancellous bone
    17
        Cortical bone
    18
    No statistical analyses for this end point

    Primary: Tissue penetration ratios

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    End point title
    		 Tissue penetration ratios [2]
    End point description
    tissue penetration expressed as the ratio of free AUCtissue/free AUCplasma
    End point type
    Primary
    End point timeframe
    From 0 to 8 hours of sampling
    Notes
    [2] - 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: The free tissue AUC0-last to free plasma AUC0-last ratio (fAUCtissue/fAUCplasma) was calculated as a measure for tissue penetration.
    End point values
    		 Overall trial
    Number of subjects analysed
    10
    Units: Percentage
    arithmetic mean (confidence interval 95%)
        Subcutaneous adipose tissue
    0.31 (0.16 to 0.46)
        Cancellous bone
    0.45 (0.29 to 0.62)
        Cortical bone
    0.17 (0.11 to 0.24)
    No statistical analyses for this end point

    Primary: Time to MIC 2

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    End point title
    		 Time to MIC 2 [3]
    End point description
    Time (min) to mean concentrations of 2 for plasma, subcutaneous adipose tissue and cancellous and cortical bone (MICs).
    End point type
    Primary
    End point timeframe
    From 0 to 8 hours of sampling
    Notes
    [3] - 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: By use of Microsoft Excel, the time to mean MICs of 1, 2, 4 and 8 mg/L was estimated using linear interpolation
    End point values
    		 Overall trial
    Number of subjects analysed
    10
    Units: Time (min)
        Plasma
    3
        Subcutaneous adipose tissue
    36
        Cancellous bone
    27
        Cortical bone
    110
    No statistical analyses for this end point

    Primary: Time to MIC 4

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    End point title
    		 Time to MIC 4 [4]
    End point description
    Time (min) to mean concentrations of 4 ug/ml for plasma, subcutaneous adipose tissue and cancellous and cortical bone (MICs).
    End point type
    Primary
    End point timeframe
    From 0 to 8 hours of sampling
    Notes
    [4] - 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: By use of Microsoft Excel, the time to mean MICs of 1, 2, 4 and 8 mg/L was estimated using linear interpolation.
    End point values
    		 Overall trial
    Number of subjects analysed
    10
    Units: Time (min)
        Plasma
    6
        Subcutaneous adipose tissue
    68
        Cancellous bone
    44
    No statistical analyses for this end point

    Primary: Time to MIC 8

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    End point title
    		 Time to MIC 8 [5]
    End point description
    Time (min) to mean concentrations of 8 mg/L for plasma, subcutaneous adipose tissue and cancellous and cortical bone (MICs).
    End point type
    Primary
    End point timeframe
    From 0 to 8 hours of sampling
    Notes
    [5] - 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: By use of Microsoft Excel, the time to mean MICs of 1, 2, 4 and 8 mg/L was estimated using linear interpolation
    End point values
    		 Overall trial
    Number of subjects analysed
    10
    Units: Time (min)
        Plasma
    11
        Cancellous bone
    105
    No statistical analyses for this end point

    Secondary: AUC

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    End point title
    		 AUC
    End point description
    AUC0–last, area under the concentration–time curve from 0 to the last measured value
    End point type
    Secondary
    End point timeframe
    From 0 to 8 hours of sampling
    End point values
    		 Overall trial
    Number of subjects analysed
    10
    Units: min ug/ml
    median (confidence interval 95%)
        Plasma
    6296 (5883 to 6709)
        Subcutaneous adipose tissue
    1545 (698 to 2392)
        Cancellous bone
    2636 (1527 to 3744)
        Cortical bone
    1016 (661 to 1371)
    No statistical analyses for this end point

    Secondary: Cmax

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    End point title
    		 Cmax
    End point description
    Cmax, peak drug concentration
    End point type
    Secondary
    End point timeframe
    From 0 to 8 hours of sampling
    End point values
    		 Overall trial
    Number of subjects analysed
    10
    Units: ug/ml
    arithmetic mean (confidence interval 95%)
        Plasma
    34.3 (31.3 to 37.2)
        Subcutaneous adipose tissue
    6.6 (3.4 to 9.8)
        Cancellous bone
    10.8 (6.3 to 15.3)
        Cortical bone
    4 (2.5 to 5.4)
    No statistical analyses for this end point

    Secondary: Tmax

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    End point title
    		 Tmax
    End point description
    Tmax, time to Cmax
    End point type
    Secondary
    End point timeframe
    From 0 to 8 hours of sampling
    End point values
    		 Overall trial
    Number of subjects analysed
    10
    Units: minute
    median (confidence interval 95%)
        Plasma
    100 (64 to 136)
        Subcutaneous adipose tissue
    200 (120 to 281)
        Cancellous bone
    148 (73 to 223)
        Cortical bone
    152 (81 to 223)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the preoperative cefuroxime administration to the end of sampling (8 hours after vancomycin administration)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Produktresumé
    Dictionary version
    21.okt2011
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 All subjects recieved the same amount of drug. No randomisation.

    Serious adverse events
    		 Overall 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: 0%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 10 (10.00%)
    Product issues
    Membrane default
    Additional description: When pulling out one of the catheters, the membrane fell of the catheter and stayed in the subcutaneous tissue. The membrane is very small and biocompatible and the manufactor of the product, MDialysis, recommended to leave it behind.
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    10

    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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