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    Clinical Trial Results:
    Assessment of the optimal dosing of piperacillin-tazobactam in intensive care unit patients: extended versus continuous infusion

    Summary
    EudraCT number
    		 2010-021050-20
    Trial protocol
    		 BE  
    Global end of trial date
    16 Nov 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Sep 2024
    First version publication date
    08 Sep 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2010/003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ghent University Hospital
    Sponsor organisation address
    Corneel Heymanslaan 10, Ghent, Belgium, 9000
    Public contact
    Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
    Scientific contact
    Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
    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
    16 Nov 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Nov 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Nov 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the standard extended dosing regimen of piperacillin-tazobactam with continuous infusion to determine the optimal dosing in an intensive care population using pharmacokinetic/pharmacodynamic approaches
    Protection of trial subjects
    Ethics review and approval, informed consent, supportive care and routine monitoring.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Sep 2010
    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
    Belgium: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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)
    14
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 14 patients were screened in the period from 23-09-2010 till 16-11-2012. 14 patients were included, 14 patients were randomised. 13 patients were included and completed the trial. End of trial notification was dated xx-mmm-yyyy (last patient last visit) and submitted to EC 24-04-2018.

    Pre-assignment
    Screening details
    		 Inclusion Criteria: Adult patients (> 18 years) admitted on the intensive care unit (surgical and medical surgery). Starting a treatment with piperacillin/tazobactam Signed informed consent Hematocrit >= 21% Available arterial line

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Extended infusion
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tazocin 4 g
    Investigational medicinal product code
    CAS 61477-96-1
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Maximum dose allowed: 16 g Intravenous use

    Arm title
    		 Continuous infusion
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tazocin 4 g
    Investigational medicinal product code
    CAS 61477-96-1
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Maximum dose allowed: 16 g Intravenous use

    Number of subjects in period 1
    		Extended infusion Continuous infusion
    Started
    7
    7
    Completed
    7
    6
    Not completed
    0
    1
         Adverse event, non-fatal
    -
    1

    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
    		 14 14
    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)
    		 0 0
        From 65-84 years
    		 14 14
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 14 14

    End points

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    End points reporting groups
    Reporting group title
    Extended infusion
    Reporting group description
    		 -

    Reporting group title
    Continuous infusion
    Reporting group description
    		 -

    Primary: Primary

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    End point title
    		 Primary
    End point description
    End point type
    Primary
    End point timeframe
    Overal study
    End point values
    		 Extended infusion Continuous infusion
    Number of subjects analysed
    7
    7
    Units: Subjects
    7
    7
    Statistical analysis title
    		 Statistical analysis
    Statistical analysis description
    Parametric data: unpaired t-test or students t-test Non-parametric data: Wilcoxon’s test Level of significance p< 0.05 Monte Carlo approach will be applied to simulate 10000 subjects for each regimen De statistical analyses will be performed with the support of “cel Gezondheidsstatistiek, UGent/UZGent”
    Comparison groups
    Extended infusion v Continuous infusion
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0
    Method
    		 See article
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Extended infusion
    Reporting group description
    		 -

    Reporting group title
    Continuous infusion
    Reporting group description
    		 -

    Serious adverse events
    		 Extended infusion Continuous infusion
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Endocrine disorders
    Acute tubular necrosis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Extended infusion Continuous infusion
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    Cardiac disorders
    Hypertension
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    hypomagnesemia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Hypophosphatemia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Thrombopenia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Hyperpotassemia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Low hematocrit
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Endocrine disorders
    Oliguria
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Anuria
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    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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