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    Clinical Trial Results:
    Does repeated administration of cefuroxime after orthopedic surgery provide a better prophylactic profile regarding postoperativ infection than a single administration of preoperative antimicrobial ? - A micro dialysis study assessing the concentration of antibiotics in bone, synovial sheath, and subcutaneous tissue after trapeziectomy

    Summary
    EudraCT number
    		 2019-001134-33
    Trial protocol
    		 DK  
    Global end of trial date
    19 May 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Oct 2022
    First version publication date
    22 Oct 2022
    Other versions
    Summary report(s)
    		 Results 2019-001134-33

    Trial information

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    Trial identification
    Sponsor protocol code
    012329
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 99 , Aarhus N , Denmark,
    Public contact
    Andrea René Jørgensen, Aarhus University Hospital, 0045 51955640, anjo@clin.au.dk
    Scientific contact
    Andrea René Jørgensen, Aarhus University Hospital, 0045 51955640, anjo@clin.au.dk
    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
    26 Sep 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 May 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    19 May 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objectives of the trial are to asses the penetration of cefuroxime when it is administered as either a single administration or as repeated administration, into bone, synovial sheath, and subcutaneous tissue with the use of the pharmacokinetic sampling method, micro dialysis. The primary endpoints are the time for which the concentration of cefuroxime is above the minimal inhibitory concentration (T>MIC) and penetration ratios. The secondary endpoints are standard pharmacokinetic parametres such as; half-life, Cmax, Tmax and AUC.
    Protection of trial subjects
    Pain medication was given as in accordance with the normal treatment in relation to the surgery. Food and drink when needed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2019
    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
    Denmark: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients requiring a trapeziectomy due to CMC1 osteoarthritis was asked.

    Pre-assignment
    Screening details
    		 Criteria for inclusion and exclusion, screened by medical doctor.

    Period 1
    Period 1 title
    Intervention (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
    		 1x1500
    Arm description
    		 Standard treatment.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    PR1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    1,500 mg of cefuroxime given as a single bolus administration intravenously over 10 min.

    Arm title
    		 2x1,500
    Arm description
    		 Repeat dose of cefuroxime.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PR1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    2x1,500 mg of cefuroxime given as a single bolus administration intravenously over 10 min 4 h apart.

    Number of subjects in period 1
    		1x1500 2x1,500
    Started
    8
    8
    Inclusion of all patients.
    8
    8
    Surgery of all patients.
    8
    8
    Data analysis of all patients.
    8
    8
    Completed
    8
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    1x1500
    Reporting group description
    		 Standard treatment.

    Reporting group title
    2x1,500
    Reporting group description
    		 Repeat dose of cefuroxime.

    Reporting group values
    		 1x1500 2x1,500 Total
    Number of subjects
    		 8 8 16
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 3 4 7
        From 65-84 years
    		 5 4 9
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 66 (51 to 80) 63 (56 to 74) -
    Gender categorical
    Units: Subjects
        Female
    		 6 7 13
        Male
    		 2 1 3

    End points

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    End points reporting groups
    Reporting group title
    1x1500
    Reporting group description
    		 Standard treatment.

    Reporting group title
    2x1,500
    Reporting group description
    		 Repeat dose of cefuroxime.

    Primary: T>MIC

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    End point title
    		 T>MIC
    End point description
    End point type
    Primary
    End point timeframe
    From time 0 and until end of the observation time (8h)
    End point values
    		 1x1500 2x1,500
    Number of subjects analysed
    8
    8
    Units: minute
    arithmetic mean (confidence interval 95%)
        Plasma
    280 (251 to 308)
    449 (421 to 478)
        Subcutaneous tissue
    336 (308 to 365)
    445 (414 to 475)
        Synovial sheath
    315 (287 to 344)
    446 (418 to 475)
        Bone
    235 (206 to 263)
    433 (405 to 462)
    Statistical analysis title
    		 ANOVA
    Comparison groups
    2x1,500 v 1x1500
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [1] - The pharmacokinetic parameters and mean fT>MIC were compared by the use of repeated measurements analysis of variance followed by pairwise comparisons by linear regression. A p-value < 0.05 was considered statistically significant

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From the time of administration of cefuroxime (T = 0) and until 8 h after (first) administration.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Produktresumé
    Dictionary version
    2016
    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 were no adverse events.

    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.
    Small sample size.
    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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