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    Clinical Trial Results:
    Concentrations of doripenem in the cerebrospinal fluid of neurointensive care patients with extraventricular drainage due to secondary obstructive hydrocephalus

    Summary
    EudraCT number
    		 2010-020920-24
    Trial protocol
    		 AT  
    Global end of trial date
    31 Oct 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Oct 2020
    First version publication date
    31 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Doripenem–CSF
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medizinische Universität Wien, Univ. Klinik f. Innere Medizin I, Abt. f. Infektionen u. Tropenmedizin
    Sponsor organisation address
    Waehringer Gürtel 18-20 , Vienna, Austria, 1090
    Public contact
    Sarah.schwarz@meduniwien.ac.at, 0043 1 4040044405, 0043 1 4040044405, Sarah.schwarz@meduniwien.ac.at
    Scientific contact
    Sarah.schwarz@meduniwien.ac.at, 0043 1 4040044405, 0043 1 4040044405, Sarah.schwarz@meduniwien.ac.at
    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
    31 Oct 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    to test the ability of doripenem to penetrate into the CSF of neurointensive care patients with extraventricular drainage due to secondary obstructive hydrocephalus
    Protection of trial subjects
    Patient were monitored at the ICU
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 May 2011
    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
    Austria: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    9
    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)
    9
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients after subarachnoidal hemorrage requiring intensive care and extraventriculardrainage due to secondary obstructive hydrocephalus, and clinical indication for tratment with doripenem.

    Pre-assignment
    Screening details
    		 Patients with subarachnoidal hemorrage requiring intensive care and extraventriculardrainage due to secondary obstructive hydrocephalus, and clinical indication for tratment with doripenem at the neurosurgical ICU (General Hospital Vienna)

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

    Arms
    Arm title
    		 Doripenem
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Doripenem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mg

    Number of subjects in period 1
    		Doripenem
    Started
    9
    Completed
    9

    Baseline characteristics

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    End points

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

    Primary: The concentration of doripenem in CSF and plasma will be measured.

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    End point title
    		 The concentration of doripenem in CSF and plasma will be measured. [1]
    End point description
    Pharmacokinetic concentration of doripenem in CSF and plasma.
    End point type
    Primary
    End point timeframe
    48h
    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: Just one Arm, descriptive design
    End point values
    		 Doripenem
    Number of subjects analysed
    9
    Units: mg/l
        number (not applicable)
    9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Patients are continuesly monitored at the ICU.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Doripenem
    Reporting group description
    		 -

    Serious adverse events
    		 Doripenem
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Doripenem
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 9 (11.11%)
    Infections and infestations
    Infection masked
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1

    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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