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    Clinical Trial Results:
    Pharmacokinetics of small spectcrum beta-lactam antibiotics (Amoxicillin/Clavulanic Acid and Cefuroxime) on intensive care.

    Summary
    EudraCT number
    2011-006107-35
    Trial protocol
    BE  
    Global end of trial date
    21 Jan 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Jul 2021
    First version publication date
    01 Jul 2021
    Other versions
    Summary report(s)
    Antimicrob Chemother 2013
    Antimicrob Chemother 2014

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2011/012
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01581047
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Ghent University Hospita
    Sponsor organisation address
    Corneel Heymanslaan 10, Ghent, Belgium, 9000
    Public contact
    Trial Bureau, Ghent University Hospital, 32 93320500, Trialbureau@uzgent.be
    Scientific contact
    Trial Bureau, Ghent University Hospital, 32 93320500, Trialbureau@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
    19 May 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the pharmacokinetics of Amoxicillin/Clavulanic acid and Cefuroxime antibiotics in patients hospitalized in the ntensive care.
    Protection of trial subjects
    Ethics review and approval, informed consent, supportive care and routine monitoring.
    Background therapy
    Adequate antibiotic therapy is very important in the treatment of infections. Spectrum and dosing of the antibiotics are two factors of the therapy: the spectrum of an antibiotic can't be changed, but the dosing scheme can be optimized. Recent studies proved that an optimized dosing scheme can improve the efficacy of the treatment. Broad-spectrum antibiotics have unpredictable pharmacokinetics in patients on intensive care units. This is due to the pathophysiologic processes in the patients on intensive care units: increased distribution volume, hypoproteinemia, organ failure… The investigators guess that similar processes influence the pharmacokinetics of small spectrum antibiotics (like amoxicillin and cefuroxime), but data lacks. Because the pharmacokinetics of broad spectrum antibiotics in seriously ill patients are better known, physicians are more confident prescribing these drugs. Studying the pharmacokinetic interactions of small spectrum antibiotics in seriously ill patients, can help to give the physician the confidence to prescribe these small-spectrum antibiotics.
    Evidence for comparator
    In this study, the investigators will study the pharmacokinetics of amoxicillin/clavulanic acid and cefuroxime, in 60 patients on intensive care. 8 blood samples will be drawn via a central catheter on different moments after one administration of the antibiotic in the steady state phase. All the patients are prescribed the antibiotics for the treatment of their infections: they get the antibiotic therapy anyway. By measuring the concentrations on different moments after one administration, the investigators can reconstruct the pharmacokinetic function.
    Actual start date of recruitment
    15 Mar 2012
    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: 37
    Worldwide total number of subjects
    37
    EEA total number of subjects
    37
    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)
    22
    From 65 to 84 years
    14
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    59 patients were screened in the period from 15-Mar-2012 till 21-Jan-2014. 37 patients were included and completed the trial. End of trial notification was dated 21-Jan-2014 (last patient last visit) and submitted to EC and CA 02-Jun-2014

    Pre-assignment
    Screening details
    Male/Female >18 Years Patients on the intensive care , who are treated with amoxicillin/clavulanic acid or cefuroxime for an infection Exclusion Criteria: informed consent lacking haematocrit < 21 % arterial catheter lacking

    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
    Amoxicillin/Clavulanic Acid
    Arm description
    Patients in the intensive care unit, with an infection which will be treated with Amoxicillin/Clavulanic Acid.
    Arm type
    Experimental

    Investigational medicinal product name
    Amoxicillin/Clavulanic Acid
    Investigational medicinal product code
    J01CR02
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    1 g 4 x/day

    Arm title
    Cefuroxime
    Arm description
    Patients in the intensive care unit, with an infection which will be treated with Cefuroxime.
    Arm type
    Experimental

    Investigational medicinal product name
    Cefuroxime
    Investigational medicinal product code
    J01D A06
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Solution for infusion
    Dosage and administration details
    1,5 g 3 x/dag

    Number of subjects in period 1
    Amoxicillin/Clavulanic Acid Cefuroxime
    Started
    16
    21
    Completed
    16
    21

    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
    37 37
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    65 (26 to 85) -
    Gender categorical
    Units: Subjects
        Female
    9 9
        Male
    28 28
    Subject analysis sets

    Subject analysis set title
    Area under the serum concentration versus time curve (AUC)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Area under the serum concentration versus time curve (AUC) of Amoxicillin/Clavulanic acid. The concentrations of the antibiotic in serum samples, drawn at various times after one administration, will be measured. With these data, we can calculate the time above the minimal inhibitory concentration (MIC). [Time Frame: Before and at 15, 30, 45, 60, 120, 240 and 360 minutes after administration]

    Subject analysis set title
    Area under the serum concentration versus time curve (AUC)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Area under the serum concentration versus time curve (AUC) of Cefuroxime. The concentrations of the antibiotic in serum samples, drawn at various times after one administration, will be measured. With these data, we can calculate the time above the minimal inhibitory concentration (MIC). [Time Frame: Before and at 15, 30, 45, 60, 120, 240 and 480 minutes after administration]

    Subject analysis sets values
    Area under the serum concentration versus time curve (AUC) Area under the serum concentration versus time curve (AUC)
    Number of subjects
    16
    21
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (full range (min-max))
    62 (58 to 72)
    69 (26 to 85)
    Gender categorical
    Units: Subjects
        Female
    3
    6
        Male
    13
    15

    End points

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    End points reporting groups
    Reporting group title
    Amoxicillin/Clavulanic Acid
    Reporting group description
    Patients in the intensive care unit, with an infection which will be treated with Amoxicillin/Clavulanic Acid.

    Reporting group title
    Cefuroxime
    Reporting group description
    Patients in the intensive care unit, with an infection which will be treated with Cefuroxime.

    Subject analysis set title
    Area under the serum concentration versus time curve (AUC)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Area under the serum concentration versus time curve (AUC) of Amoxicillin/Clavulanic acid. The concentrations of the antibiotic in serum samples, drawn at various times after one administration, will be measured. With these data, we can calculate the time above the minimal inhibitory concentration (MIC). [Time Frame: Before and at 15, 30, 45, 60, 120, 240 and 360 minutes after administration]

    Subject analysis set title
    Area under the serum concentration versus time curve (AUC)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Area under the serum concentration versus time curve (AUC) of Cefuroxime. The concentrations of the antibiotic in serum samples, drawn at various times after one administration, will be measured. With these data, we can calculate the time above the minimal inhibitory concentration (MIC). [Time Frame: Before and at 15, 30, 45, 60, 120, 240 and 480 minutes after administration]

    Primary: Area under the serum concentration versus time curve (AUC)

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    End point title
    Area under the serum concentration versus time curve (AUC) [1]
    End point description
    The concentrations of the antibiotic in serum samples, drawn at various times after one administration, will be measured. With these data, we can calculate the time above the minimal inhibitory concentration (MIC).
    End point type
    Primary
    End point timeframe
    Time Frame: Before and at 15, 30, 45, 60, 120, 240 and 360 minutes after administration Amoxicillin/Clavulanic acid Time Frame: Before and at 15, 30, 45, 60, 120, 240 and 480 minutes after administration Cefuroxime
    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
    Amoxicillin/Clavulanic Acid Cefuroxime
    Number of subjects analysed
    13
    20
    Units: CL (L/h)
        number (not applicable)
    10
    9
    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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