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    Clinical Trial Results:
    Pharmacokinetics of Tigecycline in Patients Receiving Continuous Renal Replacement Therapy

    Summary
    EudraCT number
    		 2012-005617-39
    Trial protocol
    		 DE  
    Global end of trial date
    20 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jan 2024
    First version publication date
    21 Jan 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    WS2030571
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University hospital Tuebingen
    Sponsor organisation address
    Hoppe-Seyler-Straße 3, Tuebingen, Germany, 72076
    Public contact
    Dept of Anestheseiology, University Hospital Tuebingen, 49 70712986900,
    Scientific contact
    Dept of Anestheseiology, University Hospital Tuebingen, 49 70712986900,
    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 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of the present study is to assess the pharmacokinetics of tigecycline in patients with acute renal failure receiving continuous veno-venous hemodialysis (CVVHD) with regional citrate anticoagulation or continuous veno-venous hemodiafiltration (CVVHDF) with conventional heparin-based anticoagulation. Particularly, the following parameters should be evaluated: • Area under the concentration-time curve from 0 to 12 h (AUC0-12) in 8 patients each receiving CVVHD (citrate anticoagulation) or CVVHDF (heparin anticoagulation and predilution), respectively. • Comparison of these AUC0-12 data with the values described in previous population kinetics. • Total elimination half-life of tigecycline under CVVHD and CVVHD All measurements will be taken under steady state conditions (on day 4 or later of intra-venous tigecycline treatment with an initial single dose of 100 mg iv and 50 mg iv b.i.d) after starting CVVHD or CVVHDF for at least 24 hours.
    Protection of trial subjects
    Declaration of Helsinki GCP
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 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
    Germany: 11
    Worldwide total number of subjects
    11
    EEA total number of subjects
    11
    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)
    5
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 11 patients were included in the study. the patients were treated with tigecycline due to cIAI (n=10) or infection caused by Acinetobacter baumanii (n=1)

    Pre-assignment
    Screening details
    		 Eleven patients mainly with intra-abdominal infections receiving either continuous veno-venous hemodialysis (CVVHD, n = 8) or hemodiafiltration (CVVHDF, n = 3) were enrolled, and plasma as well as effluent samples were collected according to a rich sampling schedule.

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

    Arms
    Arm title
    		 Tigecycline
    Arm description
    		 Eleven patients mainly with intra-abdominal infections receiving either continuous veno-venous hemodialysis (CVVHD, n = 8) or hemodiafiltration (CVVHDF, n = 3) were enrolled, and plasma as well as effluent samples were collected according to a rich sampling schedule. Total and free tigecycline was determined by ultrafiltration and high-performance liquid chromatography (HPLC)-UV. Population pharmacokinetic modeling using NONMEM® 7.4 was used to determine the pharmacokinetic parameters as well as the clearance of CVVHD and CVVHDF. Pharmacokinetic/pharmacodynamic target attainment analyses were performed to explore the potential need for dose adjustments of tigecycline in CRRT
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tigecycline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for dispersion for injection
    Routes of administration
    Infusion
    Dosage and administration details
    loading dose of 100 mg followed by 50mg twice daily

    Number of subjects in period 1
    		Tigecycline
    Started
    11
    Completed
    11

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Tigecycline
    Reporting group description
    		 Eleven patients mainly with intra-abdominal infections receiving either continuous veno-venous hemodialysis (CVVHD, n = 8) or hemodiafiltration (CVVHDF, n = 3) were enrolled, and plasma as well as effluent samples were collected according to a rich sampling schedule. Total and free tigecycline was determined by ultrafiltration and high-performance liquid chromatography (HPLC)-UV. Population pharmacokinetic modeling using NONMEM® 7.4 was used to determine the pharmacokinetic parameters as well as the clearance of CVVHD and CVVHDF. Pharmacokinetic/pharmacodynamic target attainment analyses were performed to explore the potential need for dose adjustments of tigecycline in CRRT

    Primary: pharmacokinetic

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    End point title
    		 pharmacokinetic [1]
    End point description
    End point type
    Primary
    End point timeframe
    samples were collected before start of infusion (time 0) and after 1h; 1,25h; 1,5h; 1,75h; 2h; 4h;6h;8h; 12h
    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: https://pubmed.ncbi.nlm.nih.gov/30558639/
    End point values
    		 Tigecycline
    Number of subjects analysed
    11
    Units: mg/dL
        number (not applicable)
    11
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    read in abstract
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Frequency threshold for reporting non-serious adverse events: 5%
    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: See the abstract, https://pubmed.ncbi.nlm.nih.gov/30558639/

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30558639
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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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