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    Clinical Trial Results:
    Pharmacokinetics study of piperacillin-tazobactam and meropenem in obese patients

    Summary
    EudraCT number
    		 2013-000652-18
    Trial protocol
    		 BE  
    Global end of trial date
    07 Feb 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Aug 2025
    First version publication date
    10 Aug 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    E2013PK-OB-PTZ-MEM
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    HUB-Hôpital Erasme
    Sponsor organisation address
    Route de Lennik 808 , Brussels, Belgium,
    Public contact
    Dr M. Hites, HUB-Hôpital Erasme, 0032 25555779, maya.hites@hubruxelles.be
    Scientific contact
    Dr M. Hites, HUB-Hôpital Erasme, 0032 25555779, maya.hites@hubruxelles.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
    07 Feb 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Aug 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Determine the pharmacokinetics parameters of broad spectrum B-lactams (piperacillin-tazobactam and meropenem) given conventional doses in obese patients.
    Protection of trial subjects
    Patients managed per standard of care procedure
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Mar 2013
    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: 71
    Worldwide total number of subjects
    71
    EEA total number of subjects
    71
    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)
    51
    From 65 to 84 years
    19
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment in Belgium

    Pre-assignment
    Screening details
    		 Obese patients (BMI ≥ 30 kg/m²) hospitalized and receiving TZP or MEM intravenously for a suspected or confirmed infection

    Pre-assignment period milestones
    Number of subjects started
    		 71
    Number of subjects completed
    		 71

    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
    Are arms mutually exclusive
    Yes

    Arm title
    		 Piperacillin-tazobactam (TZP)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Piperacillin-tazobactam (TZP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dose administered: 4 g of piperacillin / 500 mg of tazobactam per dose. Frequency of administration: Four times daily (QID), every 6 hours

    Arm title
    		 Meropenem (MEM)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Meropenem (MEM)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dose administered: 1 g (1000 mg) per dose. Frequency of administration: Three times daily (TID), every 8 hours.

    Number of subjects in period 1
    		Piperacillin-tazobactam (TZP) Meropenem (MEM)
    Started
    40
    31
    Completed
    40
    31

    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
    		 71 71
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 51 51
        From 65-84 years
    		 19 19
        85 years and over
    		 1 1
    Age continuous
    Units: years
        median (full range (min-max))
    		 50 (18 to 87) -
    Gender categorical
    Units: Subjects
        Female
    		 33 33
        Male
    		 38 38

    End points

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    End points reporting groups
    Reporting group title
    Piperacillin-tazobactam (TZP)
    Reporting group description
    		 -

    Reporting group title
    Meropenem (MEM)
    Reporting group description
    		 -

    Primary: AUC unbound concentration of Piperacillin-Tazobactam and Meropenem

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    End point title
    		 AUC unbound concentration of Piperacillin-Tazobactam and Meropenem
    End point description
    End point type
    Primary
    End point timeframe
    End of trial
    End point values
    		 Piperacillin-tazobactam (TZP) Meropenem (MEM)
    Number of subjects analysed
    40
    31
    Units: mg.h/L
    arithmetic mean (full range (min-max))
        Obese (BMI ≥ 30 kg/m²
    200 (144 to 256)
    61.53 (33.73 to 89.33)
        Non-obese (BMI < 30 kg/m²
    291 (166 to 416)
    73.52 (46.87 to 100.17)
    Statistical analysis title
    		 Pharmacokinetic Analysis of TZP
    Statistical analysis description
    Comparative Analysis of Pharmacokinetic Parameters Between Obese and Non-Obese Patients for Piperacillin-Tazobactam. This pharmacokinetic study included 40 adults (obese and non-obese) receiving piperacillin-tazobactam (4 g/500 mg IV QID). Nine blood samples were collected to assess pharmacokinetics (AUC, clearance, volume of distribution, % time fTZP >16 mg/L & 64 mg/L). Creatinine clearance was measured. Groups were compared using statistical tests (p < 0.05).
    Comparison groups
    Piperacillin-tazobactam (TZP) v Meropenem (MEM)
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.01 [2]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - Comparative statistical analysis of pharmacokinetic (PK) parameters (e.g., volume of distribution, clearance, and AUC) between obese and non-obese patients to determine differences in drug exposure.
    [2] - P-values represent statistical comparisons between obese and non-obese patients for pharmacokinetic parameters: Volume of Distribution: p = 0.010 Clearance: p = 0.007 AUC: p = 0.010 % Time fTZP > 64 mg/L: p = 0.005
    Statistical analysis title
    		 Pharmacokinetic Analysis of Meropenem
    Comparison groups
    Meropenem (MEM) v Piperacillin-tazobactam (TZP)
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.122 [4]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [3] - Comparative analysis of pharmacokinetic (PK) parameters, including volume of distribution, clearance, and % time unbound MEM > 2 mg/L, between obese and non-obese patients. This pharmacokinetic study included 31 adults (obese and non-obese) receiving meropenem (1 g IV TID). Eleven blood samples were collected to assess pharmacokinetics (AUC, clearance, volume of distribution, % time fMEM >2 mg/L). Creatinine clearance was measured. Groups were compared using statistical tests (p < 0.05).
    [4] - P-values represent statistical comparisons between obese and non-obese patients for pharmacokinetic parameters.

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    March 2013 - Dec 2018
    Adverse event reporting additional description
    Adverse events were actively monitored throughout the study. However, no adverse events were reported by patients, either serious or non-serious. The patients study duration was only 24h.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Frequency threshold for reporting non-serious adverse events: 0%
    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: There are no non-serious adverse events recorded for these results. It is expected that there will be a low incidence of adverse events due to the study's focus on pharmacokinetic evaluations in non-critically ill patients. All data related to adverse events, if any, will be monitored and documented throughout the study.

    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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