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    Clinical Trial Results:
    Pharmacokinetic evaluation of fluoroquinolone antibiotics administered intravenously in intensive care patients with normal renal function and with renal hyperfiltration

    Summary
    EudraCT number
    		 2010-019691-70
    Trial protocol
    		 BE  
    Global end of trial date
    01 Dec 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Jul 2021
    First version publication date
    09 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2010/002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01109823
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Ghent
    Sponsor organisation address
    C. Heymanslaan 10 , Ghent, Belgium, 9000
    Public contact
    Universitair Ziekenhuis Gentl | C. Heymanslaan 10 | 9000 Gent | Ingang 12, route 1280A , Universitair Ziekenhuis Ghent, 0032 3326219, Jan.DeWaele@UGent.be
    Scientific contact
    Universitair Ziekenhuis Gentl | C. Heymanslaan 10 | 9000 Gent | Ingang 12, route 1280A , Universitair Ziekenhuis Ghent, 0032 3326219, Jan.DeWaele@UGent.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
    01 Dec 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To describe the pharmacokinetics of fluoroquinolone antibiotics intravenously administered in intensive care patients with renal hyperfiltration, in comparison with patients with normal renal function.
    Protection of trial subjects
    Ethics review and approval, informed consent, supportive care and routine monitoring.
    Background therapy
    		 At the intensive care unit (ICU) fluoroquinolone antibiotics, like levofloxacin, are frequently used for the treatment of infections. Efficient antibiotic therapy is very important in this setting, and more specifically, the spectrum of the antibiotic and the dosage are essential. It is almost impossible to change the spectrum of an antibiotic, but recent literature demonstrated that optimizing dosage improved the efficacy of therapy. Adequate blood levels are required for a good efficacy of the antibiotic. Due to the fact that levofloxacin is almost completely eliminated renally, the blood levels for this antibiotic are strongly influenced by the renal function. This renal function can be normal in critically ill patients; however, hyperfiltration (due to an increased blood flow in the kidney) can also occur in this population. In a recent study from the department, up to 55 percent of patients receiving anti-infective treatment had some degree of hyperfiltration. The pharmacokinetics of intravenously administered levofloxacin has not yet been studied in patients with renal hyperfiltration. This study therefore aimed to evaluate the pharmacokinetics of levofloxacin in these patients, in comparison with critically ill patients with normal renal function.
    Evidence for comparator
    		 In 20 patients of each group (patients with normal renal function and patients with renal hyperfiltration), the pharmacokinetics of levofloxacin will be studied. Blood sampling will be performed at 12 time points and for each sample 5ml blood will be taken. This study will be performed under steady state conditions (at least 32h after the first dose was given)
    Actual start date of recruitment
    19 May 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)
    7
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 14 patients were screened in the period from 19-May-2010 till 01-Dec-2013. 14 patients were included and completed the trial. End of trial notification was dated 01-Dec-2013 (last patient last visit) and submitted to EC and CA 31-Jun-2017.

    Pre-assignment
    Screening details
    		 Patients hospitalized at the Department Intensive Care Unit who are being treated with Tavanic I.V. (500mg, twice daily) for an infection. Exclusion criteria: · Younger than 18 years · No informed consent · No arterial catheter · Hematocrite ≤ 21 · Pregnancy and lactation · Creatinine clearance < 80 ml/min

    Pre-assignment period milestones
    Number of subjects started
    		 14
    Number of subjects completed
    		 14

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Patients with normal renal function
    Arm description
    		 Patients with normal renal function hospitalized at the Department Intensive Care Unit who are being treated with levofloxacin I.V. (500mg, twice daily) for an infection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tavanic
    Investigational medicinal product code
    BE192875
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Infusion
    Dosage and administration details
    The commercially available Tavanic® I.V. 5mg/ml (100ml) One milliliter of solution for infusion contains 5.1246 mg levofloxacinehemihydrate. Dosing: 500 mg levofloxacin as a 1-hour infusion, twice daily

    Arm title
    		 Patients with hyperfiltration
    Arm description
    		 Patients with hyperfiltration hospitalized at the Department Intensive Care Unit who are being treated with levofloxacin I.V. (500mg, twice daily) for an infection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tavanic
    Investigational medicinal product code
    BE192875
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Infusion
    Dosage and administration details
    The commercially available Tavanic® I.V. 5mg/ml (100ml) One milliliter of solution for infusion contains 5.1246 mg levofloxacinehemihydrate. Dosing: 500 mg levofloxacin as a 1-hour infusion, twice daily

    Number of subjects in period 1
    		Patients with normal renal function Patients with hyperfiltration
    Started
    8
    6
    Completed
    7
    6
    Not completed
    1
    0
         Protocol deviation
    1
    -

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Patients with normal renal function
    Reporting group description
    		 Patients with normal renal function hospitalized at the Department Intensive Care Unit who are being treated with levofloxacin I.V. (500mg, twice daily) for an infection.

    Reporting group title
    Patients with hyperfiltration
    Reporting group description
    		 Patients with hyperfiltration hospitalized at the Department Intensive Care Unit who are being treated with levofloxacin I.V. (500mg, twice daily) for an infection.

    Subject analysis set title
    Creatinine Clearance
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    A validated HPLC-method with fluorescence detection will be used for the analysis of the plasma samples at the Laboratory of Medical Biochemistry and Clinical Analysis, Faculty of Pharmaceutical Sciences, Ghent University

    Primary: CL/TVCL

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    End point title
    		 CL/TVCL [1]
    End point description
    Blood samples will be taken before, during and after the administration of one dose of Tavanic. The present arterial catheter will be used for sampling.
    End point type
    Primary
    End point timeframe
    Blood samples will be taken before (1), during (1) and after the administration (10) of one dose of Tavanic.
    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: No statistical analysis available
    End point values
    		 Patients with normal renal function Patients with hyperfiltration
    Number of subjects analysed
    7
    6
    Units: ratio
        median (full range (min-max))
    0.8 (0.6 to 1.3)
    1.3 (0.6 to 2.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Overall study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5
    Frequency threshold for reporting non-serious adverse events: 0.05%
    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: No non-serious adverse events were recorded for the participating patients

    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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