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    Clinical Trial Results:
    Concentration of Meropenem in Plasma and Subcutis in Patients on ECMO Treatment

    Summary
    EudraCT number
    2015-000218-23
    Trial protocol
    DK  
    Global end of trial date
    04 May 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Dec 2017
    First version publication date
    14 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    131188
    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
    Pelle Hanberg, Aarhus University Hospital, 0045 28744852, pellehanberg@hotmail.com
    Scientific contact
    Pelle Hanberg, Aarhus University Hospital, 0045 28744852, pellehanberg@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
    01 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    04 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective og this trial is to asses the penetration og meropenem into subcutis using the pharmacokinetic tool microdialysis. The primary endpoint is the time above the minimal inhibitory concentration (T>MIC). 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 Apr 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    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)
    8
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Criteria to fulfil: age 18 or above, in treatment with meropenem, ongoing ECMO-treatment (<96 hours since start-up of ECMO-treatment, heavily sedated). Exclusion criteria: allergy to meropenem, pregnancy.

    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 either 1,000 or 2,000 milligrams of meropenem. No randomisation.
    Arm type
    All subjects recieved the same amount of drug

    Investigational medicinal product name
    meropenem "eberth"
    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
    1,000 or 2,000 mg milligram(s) administered over 5 min. Patient 1, 2, 3, 4, 6, 9, and 10 received 1,000 mg. Patient 5, 7, and 8 received 2,000 mg.

    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)
    8 8
        From 65-84 years
    2 2
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    4 4
        Male
    6 6
    Subject analysis sets

    Subject analysis set title
    overall trial
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Concentrations values of meropenem in subcutis and plasma.

    Subject analysis sets values
    overall trial
    Number of subjects
    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)
    8
        From 65-84 years
    2
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    4
        Male
    6

    End points

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    End points reporting groups
    Reporting group title
    overall trial
    Reporting group description
    All subjects recieved either 1,000 or 2,000 milligrams of meropenem. No randomisation.

    Subject analysis set title
    overall trial
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Concentrations values of meropenem in subcutis and plasma.

    Primary: overall trial

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    End point title
    overall trial [1]
    End point description
    concentrations in milligrams/litre at the following points: subcutis: 7.5 min, 22.5 min, 37.5 min, 52.5 min, 75 min, 105 min, 135 min, 165 min, 195 min, 225 min, 285 min, 330 min, 390 min, 450 min. Plasma: 10 min, 20 min, 30 min, 45 min, 60 min, 120 min, 180 min, 240 min, 480 min. Furthermore, two blood samples were collected on day 2, 4, and 6 at time 60 min and 480 min after the second meropenem dose administrated that day.
    End point type
    Primary
    End point timeframe
    from time 0 to day 6
    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: Under "Charts" the full dataset has been uploaded as a PDF-file. All measured meropenem values from subcutis and plasma (in milligrams/L) from all the patients are included ind the file. With this dataset, people can make their owen statistical analyses.
    End point values
    overall trial overall trial
    Number of subjects analysed
    10
    10
    Units: milligram(s)/litre
        number (not applicable)
    10
    10
    Attachments
    Patient meropenem concentrations
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    from placement of the microdialysis catheter until the last collected blood sample at day 6.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    produktresume
    Dictionary version
    20.okt2014
    Reporting groups
    Reporting group title
    overall trial
    Reporting group description
    All subjects recieved either 1,000 or 2,000 milligrams of meropenem. 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
    0 / 10 (0.00%)
    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: We had no non-serious adverse event in this trial.

    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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