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    Clinical Trial Results:
    Offene, monozentrische, nicht kontrollierte und nicht randomisierte Phase IV-Studie zur Bestimmung der Pharmakokinetik von Carbapenemen in adipösen Patienten.

    Summary
    EudraCT number
    		 2010-024094-39
    Trial protocol
    		 DE  
    Global end of trial date
    01 Jul 2015

    Results information
    Results version number
    		 v1
    This version publication date
    03 Apr 2021
    First version publication date
    03 Apr 2021
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    Adip-2010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01407965
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospital Ulm
    Sponsor organisation address
    Albert-Einstein-Allee 29, Ulm, Germany, 89081
    Public contact
    Frau Prof. Dr. med. D. Henne-Bruns, Dr. med. M. Wittau, Klinik für Allgemein- und Viszeralchirurgie, 49 731 500 53500, mathias.wittau@uniklinik-ulm.de
    Scientific contact
    Frau Prof. Dr. med. D. Henne-Bruns, Dr. med. M. Wittau, Klinik für Allgemein- und Viszeralchirurgie, 49 731 500 53500, mathias.wittau@uniklinik-ulm.de
    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 Jul 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to determine the free tissue kinetics of ertapenem and meropenem in fatty tissue and intraperitoneal fluid up to 24 hours after administration of the IMP. Subjects are patients. Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at intraabdominal organs with a BMI >= 40 will be eligible for this study. Further, the free and bound plasma concentration of the IMPs will be determined.
    Protection of trial subjects
    N/A
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jun 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
    Germany: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    13
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment started on 30-Jun-2011; first patient was enrolled (FPI) on 13-Aug-2012; in total 13 subjects have been recruited, country: Germany

    Pre-assignment
    Screening details
    		 N.A.

    Pre-assignment period milestones
    Number of subjects started
    		 13
    Number of subjects completed
    		 13

    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
    		 active
    Arm description
    		 Meropenem + Ertapenem
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meropenem
    Investigational medicinal product code
    38592.02.00
    Other name
    Meronem
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intracavernous use
    Dosage and administration details
    infusion of 1 g in 100 ml 0.9% sodium chloride over 15 min

    Investigational medicinal product name
    Ertapenem
    Investigational medicinal product code
    EU/1/02/216/001 + EU/1/02/216/002
    Other name
    Invanz
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    infusion of 1 g ertapenem in 100 ml of 0.9% sodium chloride over 15 min

    Number of subjects in period 1
    		active
    Started
    13
    Completed
    12
    Not completed
    1
         Physician decision
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 All subjects

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 13 13
    Age categorical
    All subjects
    Units: Subjects
        Adults (18-64 years)
    		 13 13
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    active
    Reporting group description
    		 Meropenem + Ertapenem

    Primary: Pharmacokinetics

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    End point title
    		 Pharmacokinetics [1]
    End point description
    semikontinuierliche Messung der Kinetik der freien Konzentration von Ertapenem und Meropenem in Peritonealflüssigkeit, Fettgewebe und Plasma von adipösen Patienten (BMI 40).
    End point type
    Primary
    End point timeframe
    up to 24 hours
    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: Descriptive analysis of antibiotic concentration
    End point values
    		 active
    Number of subjects analysed
    12
    Units: mg/L
        number (not applicable)
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from signing informed consent until discharge of patient
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 verbatim
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 All patients included

    Serious adverse events
    		 Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (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
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 13 (7.69%)
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Aug 2011
    G.3. Central Technical Facilities changed
    12 Aug 2013
    G1.1 Change in address of PI and trial site; B.1.2.1 Change in name

    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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