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    Clinical Trial Results:
    Pharmacokinetics of fosfomycin: a study in patients with prolonged treatment for urinary tract infection

    Summary
    EudraCT number
    2018-000616-25
    Trial protocol
    NL  
    Global end of trial date
    01 Jan 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    25 Dec 2021
    First version publication date
    25 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    T17-084
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Haga Teaching Hospital
    Sponsor organisation address
    Els Borst-Eijlersplein 245, The Hague, Netherlands,
    Public contact
    S.G. Kuiper, Haga Teaching Hospital, s.g.kuiper@lumc.nl
    Scientific contact
    S.G. Kuiper, Haga Teaching Hospital, s.g.kuiper@lumc.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
    07 Feb 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Oct 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the pharmacokinetics of fosfomycine in patients with prolonged fosfomycin therapy to treat urinary tract infection
    Protection of trial subjects
    none
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Apr 2018
    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: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    5
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment was done from July 2019 till September 2019 in Haga Teaching Hospital, The Hague, The Netherlands

    Pre-assignment
    Screening details
    15 patients were screened and 12 were included in the trial.

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

    Arms
    Arm title
    Fosfomycin
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Fosfomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    3 gram once

    Investigational medicinal product name
    Fosfomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    3 gram intravenous

    Number of subjects in period 1
    Fosfomycin
    Started
    12
    Completed
    12

    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
    12 12
    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))
    66 (44 to 76) -
    Gender categorical
    Units: Subjects
        Female
    9 9
        Male
    3 3
    BMI
    Units: kg/m2
        median (full range (min-max))
    26.8 (20.4 to 28.7) -
    Renal function (eGFR)
    Units: ml/min/1.73 m2
        median (full range (min-max))
    83 (63 to 103) -

    End points

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    End points reporting groups
    Reporting group title
    Fosfomycin
    Reporting group description
    -

    Primary: Fosfomycin serum concentrations

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    End point title
    Fosfomycin serum concentrations [1]
    End point description
    End point type
    Primary
    End point timeframe
    -
    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 analysis is done.
    End point values
    Fosfomycin
    Number of subjects analysed
    12
    Units: mg/L
        number (not applicable)
    12
    Attachments
    Untitled (Filename: 20200120.IndividualPlotsLog.Model60.png)
    No statistical analyses for this end point

    Primary: Pharmacokinetic parameters

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    End point title
    Pharmacokinetic parameters [2]
    End point description
    End point type
    Primary
    End point timeframe
    -
    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: No statistical analysis is done.
    End point values
    Fosfomycin
    Number of subjects analysed
    12
    Units: parameter estimate
    12
    Attachments
    Untitled (Filename: Figuur 2 2020-01-20- Predictions - VPC_Jasper.png)
    No statistical analyses for this end point

    Primary: Urine fosfomycin concentration at day 1

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    End point title
    Urine fosfomycin concentration at day 1 [3]
    End point description
    End point type
    Primary
    End point timeframe
    -
    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: No statistical analysis is done.
    End point values
    Fosfomycin
    Number of subjects analysed
    12
    Units: mg/L
        geometric mean (standard deviation)
    622.3 ± 335.1
    No statistical analyses for this end point

    Primary: Urine fosfomycine concentration at day 2

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    End point title
    Urine fosfomycine concentration at day 2 [4]
    End point description
    End point type
    Primary
    End point timeframe
    -
    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: No statistical analysis is done.
    End point values
    Fosfomycin
    Number of subjects analysed
    12
    Units: mg/L
        geometric mean (standard deviation)
    41.4 ± 17.1
    No statistical analyses for this end point

    Primary: Urine fosfomycin concentration at day 3

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    End point title
    Urine fosfomycin concentration at day 3 [5]
    End point description
    End point type
    Primary
    End point timeframe
    -
    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: No statistical analysis is done.
    End point values
    Fosfomycin
    Number of subjects analysed
    12
    Units: mg/L
        geometric mean (standard deviation)
    20.5 ± 45.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    1 month
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Fosfomycin
    Reporting group description
    -

    Serious adverse events
    Fosfomycin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Fosfomycin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 12 (66.67%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 12 (58.33%)
         occurrences all number
    7
    General disorders and administration site conditions
    Tiredness
         subjects affected / exposed
    8 / 12 (66.67%)
         occurrences all number
    8
    Gastrointestinal disorders
    Gastro-intestinal complaints
         subjects affected / exposed
    8 / 12 (66.67%)
         occurrences all number
    8

    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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