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    Clinical Trial Results:
    MEROPENEM and CIPROFLOXACIN DOSING IN THE CRITICALLY ILL PATIENT WITH SEPTIC SHOCK – A SINGLE CENTER PHARMACOKINETIC STUDY

    Summary
    EudraCT number
    		 2014-002555-26
    Trial protocol
    		 DK  
    Global end of trial date
    31 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 May 2022
    First version publication date
    20 May 2022
    Other versions
    Summary report(s)
    		 Results summary MacDIPSS
    MacDIPSS publication

    Trial information

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    Trial identification
    Sponsor protocol code
    RH-RBWH-2014-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02240277
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark,
    Public contact
    Clinical Trials Information, Dept. of Intensive Care Medicine, karl.fredrik.lennart.sjoevall@regionh.dk
    Scientific contact
    Clinical Trials Information, Dept. of Intensive Care Medicine, karl.fredrik.lennart.sjoevall@regionh.dk
    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
    09 May 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate present meropenem and ciprofloxacin dosing and achieved plasma concentrations in relation to bacterial susceptibility in patients with septic shock.
    Protection of trial subjects
    Regular patient protection and insurance
    Background therapy
    		 Usual care
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    03 Nov 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: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    15
    From 65 to 84 years
    35
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Pt admitted to the ICU with either meropenem or ciprofloxacin treatment were elegible for testing.

    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
    		 Rigshospitalet
    Arm description
    		 Meropenem and ciprofloxacin
    Arm type
    		 observational

    Investigational medicinal product name
    meropenem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Standard dosing according to treating doctor

    Number of subjects in period 1
    		Rigshospitalet
    Started
    50
    Completed
    50

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Rigshospitalet
    Reporting group description
    		 Meropenem and ciprofloxacin

    Primary: Plasma concentration

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    End point title
    		 Plasma concentration [1]
    End point description
    End point type
    Primary
    End point timeframe
    During the treatment period
    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: Observational study with proportions and montecarlo simulation
    End point values
    		 Rigshospitalet
    Number of subjects analysed
    50
    Units: g/L
        number (not applicable)
    50
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    ASAP
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 1%
    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 non serious adverse events were recorded

    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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