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    Clinical Trial Results:
    Therapeutic drug monitoring (TDM) for personalized antibiotic treatment with piperacillin-tazobactam (PipTaz) in patients with febrile neutropenia after myelo-suppressive cytostatic chemotherapy

    Summary
    EudraCT number
    		 2016-002388-33
    Trial protocol
    		 DE  
    Global end of trial date
    06 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Dec 2020
    First version publication date
    09 Dec 2020
    Other versions
    Summary report(s)
    		 Study Report

    Trial information

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    Trial identification
    Sponsor protocol code
    ZKSJ0086
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Friedrich-Schiller University Jena
    Sponsor organisation address
    Bachstraße 18, Jena, Germany, 07743
    Public contact
    Prof. Marie von Lilienfeld-Toal, Jena University Hospital , +49 364193924210, marie.von_lilienfeld-toal@med.uni-jena.de
    Scientific contact
    Prof. Marie von Lilienfeld-Toal, Jena University Hospital , +49 36419324210, marie.von_lilienfeld-taol@med.uni-jena.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
    07 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jun 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary goal of the study is to examine if and in which extent the effect of a dose adjusted administration of piperacillin/tazobactam after therapeutic drug monitoring has a benefit on a stable fever recovery without changing the anti infective therapy in patients with neutropenia after myelo-suppressive cytostatic chemotherapy
    Protection of trial subjects
    (S)AEs have been documented and reported as appropriate. According to protocol, patients were followed up.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Nov 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 38
    Worldwide total number of subjects
    38
    EEA total number of subjects
    38
    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)
    26
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment: 25.11.2016 to 07.05.2018 only in Jena (Germany)

    Pre-assignment
    Screening details
    		 153 patients were pre-screened. Of those 77 patients were screened. 38 patients could be randomized.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pip/Taz with dose adjustment
    Arm description
    		 The dose adjustment of piperacillin/tazobactam follows a predefined scheme depending on the measured plasma concentration after half of the application interval (usually after 4 hours).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Piperacillin/Tazobatam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    First 4/0.5g Pip/Taz bolus over 15-30 minutes for all participants, then adjust dose according to 4-hour plasma levels for piperacillin. Daily for the first three days of treatment with Pip/Taz according to the measured plasma levels after the first application of the day or the first application in the study, further therapy is performed with the dose after the last dose adjustment In case of plasma levels >160mg/l (10xMHK), dose adjustment is made until the levels are <160mg/l after 4 hours. In case of a delayed result (6-8h after administration), the next administration is continued as before and the dose adjustment is only implemented with the next but one administration. Maximum dose 24g piperacillin (plus 3g tazobactam) in 24 hours.

    Arm title
    		 Pip/Taz without dose adjustment
    Arm description
    		 Piperacillin/tazobactam is also administered in this study arm, but no dose adjustment is made. In accordance with in-house standards, 4/0.5g Pip/Taz is administered 3x/day. The maximum dose is 12g piperacillin in 24h.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Piperacillin/Tazobatam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    According to in-house standard 4/0.5g Pip/Taz are applied 3x/day. The maximum dose is 12g Piperacillin in 24h.

    Number of subjects in period 1
    		Pip/Taz with dose adjustment Pip/Taz without dose adjustment
    Started
    19
    19
    Completed
    18
    19
    Not completed
    1
    0
         investigational product not received
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pip/Taz with dose adjustment
    Reporting group description
    		 The dose adjustment of piperacillin/tazobactam follows a predefined scheme depending on the measured plasma concentration after half of the application interval (usually after 4 hours).

    Reporting group title
    Pip/Taz without dose adjustment
    Reporting group description
    		 Piperacillin/tazobactam is also administered in this study arm, but no dose adjustment is made. In accordance with in-house standards, 4/0.5g Pip/Taz is administered 3x/day. The maximum dose is 12g piperacillin in 24h.

    Reporting group values
    		 Pip/Taz with dose adjustment Pip/Taz without dose adjustment Total
    Number of subjects
    		 19 19 38
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 13 13 26
        From 65-84 years
    		 6 6 12
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.1 ( 11.9 ) 58.1 ( 11.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 9 19
        Male
    		 9 10 19
    Subject analysis sets

    Subject analysis set title
    primary analysis
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized patients with at least one drug administration.

    Subject analysis set title
    secondary analysis
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All randomized patients which are adherent to the protocol.

    Subject analysis sets values
    		 primary analysis secondary analysis
    Number of subjects
    36
    22
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    24
    16
        From 65-84 years
    12
    6
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    55.3 ( 12.3 )
    58.1 ( 11.6 )
    Gender categorical
    Units: Subjects
        Female
    17
    10
        Male
    19
    12

    End points

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    End points reporting groups
    Reporting group title
    Pip/Taz with dose adjustment
    Reporting group description
    		 The dose adjustment of piperacillin/tazobactam follows a predefined scheme depending on the measured plasma concentration after half of the application interval (usually after 4 hours).

    Reporting group title
    Pip/Taz without dose adjustment
    Reporting group description
    		 Piperacillin/tazobactam is also administered in this study arm, but no dose adjustment is made. In accordance with in-house standards, 4/0.5g Pip/Taz is administered 3x/day. The maximum dose is 12g piperacillin in 24h.

    Subject analysis set title
    primary analysis
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized patients with at least one drug administration.

    Subject analysis set title
    secondary analysis
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All randomized patients which are adherent to the protocol.

    Primary: freedom of fever after 5 consecutive days

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    End point title
    		 freedom of fever after 5 consecutive days
    End point description
    End point type
    Primary
    End point timeframe
    30 days after randomization
    End point values
    		 Pip/Taz with dose adjustment Pip/Taz without dose adjustment
    Number of subjects analysed
    17
    19
    Units: number of patients
        yes
    5
    8
        no
    12
    11
    Statistical analysis title
    		 Chi-square test
    Comparison groups
    Pip/Taz with dose adjustment v Pip/Taz without dose adjustment
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.429
    Method
    		 Chi-squared
    Confidence interval

    Secondary: number of antibiotica free days during hospital stay

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    End point title
    		 number of antibiotica free days during hospital stay
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after randomization
    End point values
    		 Pip/Taz with dose adjustment Pip/Taz without dose adjustment
    Number of subjects analysed
    17
    19
    Units: days
        median (inter-quartile range (Q1-Q3))
    12 (10 to 14)
    14 (11 to 19)
    Statistical analysis title
    		 Mann-Whitney U Test
    Comparison groups
    Pip/Taz with dose adjustment v Pip/Taz without dose adjustment
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.167
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Admission to Intensive Care

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    End point title
    		 Admission to Intensive Care
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after randomization
    End point values
    		 Pip/Taz with dose adjustment Pip/Taz without dose adjustment
    Number of subjects analysed
    17
    19
    Units: number of patients
        yes
    1
    0
        no
    16
    19
    Statistical analysis title
    		 Chi-square test
    Comparison groups
    Pip/Taz without dose adjustment v Pip/Taz with dose adjustment
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.472
    Method
    		 Chi-squared
    Confidence interval

    Secondary: hospital stay

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    End point title
    		 hospital stay
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after randomization
    End point values
    		 Pip/Taz with dose adjustment Pip/Taz without dose adjustment
    Number of subjects analysed
    17
    19
    Units: days
        median (inter-quartile range (Q1-Q3))
    23 (20 to 32)
    29 (24 to 35)
    Statistical analysis title
    		 Mann-Whitney U Test
    Comparison groups
    Pip/Taz with dose adjustment v Pip/Taz without dose adjustment
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.146
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Duration of antibiotica therapy

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    End point title
    		 Duration of antibiotica therapy
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after randomization
    End point values
    		 Pip/Taz with dose adjustment Pip/Taz without dose adjustment
    Number of subjects analysed
    17
    19
    Units: days
        median (inter-quartile range (Q1-Q3))
    6.3 (3.6 to 8.5)
    5.9 (3.7 to 8.6)
    Statistical analysis title
    		 Mann-Whitney U Test
    Comparison groups
    Pip/Taz without dose adjustment v Pip/Taz with dose adjustment
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.924
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Cumulative dose piperacillin day 1 to day 3

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    End point title
    		 Cumulative dose piperacillin day 1 to day 3
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 to 3 after randomization
    End point values
    		 Pip/Taz with dose adjustment Pip/Taz without dose adjustment
    Number of subjects analysed
    17
    19
    Units: gram(s)
        median (inter-quartile range (Q1-Q3))
    36 (36 to 40)
    36 (36 to 36)
    Statistical analysis title
    		 Mann-Whitney U Test
    Comparison groups
    Pip/Taz with dose adjustment v Pip/Taz without dose adjustment
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.397
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Cumulative dose tazobactam day 1 to day 3

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    End point title
    		 Cumulative dose tazobactam day 1 to day 3
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 to day 3 after randomization
    End point values
    		 Pip/Taz with dose adjustment Pip/Taz without dose adjustment
    Number of subjects analysed
    17
    19
    Units: gram(s)
        median (inter-quartile range (Q1-Q3))
    4.5 (4.5 to 5)
    4.5 (4.5 to 4.5)
    Statistical analysis title
    		 Mann-Whitney U Test
    Comparison groups
    Pip/Taz with dose adjustment v Pip/Taz without dose adjustment
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.397
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: SIRS: temperature >= 38° or <=36° at final visit

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    End point title
    		 SIRS: temperature >= 38° or <=36° at final visit
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after randomization
    End point values
    		 Pip/Taz with dose adjustment Pip/Taz without dose adjustment
    Number of subjects analysed
    17
    19
    Units: number of patients
        yes
    0
    0
        no
    17
    19
    Statistical analysis title
    		 Chi-square test
    Comparison groups
    Pip/Taz with dose adjustment v Pip/Taz without dose adjustment
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval

    Secondary: SIRS: tachycardia (heart rate >= 90 per minute) at final visit

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    End point title
    		 SIRS: tachycardia (heart rate >= 90 per minute) at final visit
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after randomization
    End point values
    		 Pip/Taz with dose adjustment Pip/Taz without dose adjustment
    Number of subjects analysed
    17
    19
    Units: number of patients
        yes
    6
    7
        no
    11
    12
    Statistical analysis title
    		 Chi-square test
    Comparison groups
    Pip/Taz with dose adjustment v Pip/Taz without dose adjustment
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval

    Secondary: SIRS: Leucocytosis (>=12.000/mm³) or Leucopenia (<=4.000/mm³)

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    End point title
    		 SIRS: Leucocytosis (>=12.000/mm³) or Leucopenia (<=4.000/mm³)
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after randomization
    End point values
    		 Pip/Taz with dose adjustment Pip/Taz without dose adjustment
    Number of subjects analysed
    17
    19
    Units: number of patients
        yes
    8
    12
        no
    9
    7
    Statistical analysis title
    		 Chi-square test
    Comparison groups
    Pip/Taz with dose adjustment v Pip/Taz without dose adjustment
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.493
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Ampicillin resistance

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    End point title
    		 Ampicillin resistance
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after randomization
    End point values
    		 Pip/Taz with dose adjustment Pip/Taz without dose adjustment
    Number of subjects analysed
    17
    19
    Units: number of patients
        yes
    6
    4
        no
    11
    15
    Statistical analysis title
    		 Chi-square test
    Comparison groups
    Pip/Taz with dose adjustment v Pip/Taz without dose adjustment
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Piperacillin resistance

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    End point title
    		 Piperacillin resistance
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after randomization
    End point values
    		 Pip/Taz with dose adjustment Pip/Taz without dose adjustment
    Number of subjects analysed
    17
    19
    Units: number of patients
        yes
    0
    0
        no
    17
    19
    Statistical analysis title
    		 Chi-square test
    Comparison groups
    Pip/Taz with dose adjustment v Pip/Taz without dose adjustment
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The detection of AEs begins with randomization. The end of AE detection is reached 24h after the 5th day of stable defibrillation or, if this is not achieved with Pip/Taz alone, 24h after the end of monotherapy with Pip/Taz in patients receivi
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Pip/Taz with dose adjustment
    Reporting group description
    		 The dose adjustment of piperacillin/tazobactam follows a predefined scheme depending on the measured plasma concentration after half of the application interval (usually after 4 hours).

    Reporting group title
    Pip/Taz without dose adjustment
    Reporting group description
    		 Piperacillin/tazobactam is also administered in this study arm, but no dose adjustment is made. In accordance with in-house standards, 4/0.5g Pip/Taz is administered 3x/day. The maximum dose is 12g piperacillin in 24h.

    Serious adverse events
    		 Pip/Taz with dose adjustment Pip/Taz without dose adjustment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 19 (5.26%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         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: 5%
    Non-serious adverse events
    		 Pip/Taz with dose adjustment Pip/Taz without dose adjustment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 19 (26.32%)
    6 / 19 (31.58%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Pericardial effusion
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Palpitations
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Nervous system disorders
    Intercostal neuralgia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Mucosal inflammation
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    2 / 19 (10.53%)
    2 / 19 (10.53%)
         occurrences all number
    2
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Sep 2016
    The requirements of the Ethics Committee and the comments of the BfArM were integrated into the trial protocol and patient information after the initial application. Changes in the protocol included additional signature lines for the responsible analyst at the Institute for Clinical Chemistry and Laboratory Diagnostics and the supplier of the investigational product to the UKJ pharmacy, information on the dosage and application of Pip/Taz and the indication that patient consent must be obtained before the onset of fever. In addition, further information was provided on the criteria for discontinuation. Changes in the patient information included the revision of some of the contents (including terms understood by laypersons, optional information for the family doctor, dosage/application according to in-house standards). The approval or approving assessment is dated 24.10.2016 and 10.10.2016.
    24 Oct 2017
    Substantial Amendment regarding an additional deputy of the PI.

    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
    For support, Contact us.
    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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