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    Clinical Trial Results:
    A Cluster Crossover Trial Comparing Conventionl vs Incremental Antibiotic Therapy for the Prevention or Arrhytmia Device Infection

    Summary
    EudraCT number
    		 2014-000459-10
    Trial protocol
    		 NL  
    Global end of trial date
    08 Sep 2017

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

    Trial information

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    Trial identification
    Sponsor protocol code
    PADIT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01628666
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Canadian Institutes of Health Research
    Sponsor organisation address
    160 Elgin Street, 10th Floor , Ottawa, Canada, 4809A
    Public contact
    Marco Alings, Werkgroep Cardiologische Centra Nederland, +31 76595 4166, marco@alings.org
    Scientific contact
    Marco Alings, Werkgroep Cardiologische Centra Nederland, +31 76595 4166, marco@alings.org
    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
    18 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The goal of the study is to compare whether a centre-wide policy of incremental antibiotic therapy will reduce device infection compared to a policy of conventional antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures.
    Protection of trial subjects
    Standard non-antibiotic operating procedures to reduce infection will be continued in each centre.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Dec 2012
    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
    Canada: 18893
    Country: Number of subjects enrolled
    Netherlands: 710
    Worldwide total number of subjects
    19603
    EEA total number of subjects
    710
    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)
    19603
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited in 28 centers. 24 centers in Canada and 4 centers in the Netherlands.

    Pre-assignment
    Screening details
    		 Because there is a risk of infection with every device procedure, it would be reasonable to include data from all patients receiving a device in the analysis. However we will only include data from patients at higher risk of infection for reasons of study efficiency.

    Period 1
    Period 1 title
    Randomisation (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Both patient and operator were aware of the open-label treatment. Design was cluster randomisation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Conventional arm
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cefazolin/Vancomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    CONVENTIONAL THERAPY Conventional antibiotic therapy will be a single preoperative dose of intravenous Cefazolin 1-2g iv 60 minutes prior to skin incision. In penicillin-allergic patients, Vancomycin will be used instead at a dose of 1-1.5g iv given over 60-90 minutes, 60-90 minutes prior to skin incision.

    Arm title
    		 Incremental therapy
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Bacitracin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Topical use
    Dosage and administration details
    INCREMENTAL THERAPY Pre-procedure antibiotics will consist of a single dose of both Cefazolin 1-2g iv 60 minutes prior to skin incision plus a single dose of Vancomycin 1-1.5g iv given over 60-90 minutes, 60-90 minutes prior to incision. Because only a single dose of Vancomycin is administered, there is no need to adjust dosing in patients with renal failure. Penicillin-allergic patients will only receive Vancomycin. Patients will also receive intracavitary antibacterial wash with 50,000 units Bacitracin powder diluted in 10 ml sterile saline in the vial, shaken to dissolve the Bacitracin powder, and then placed in 50 ml sterile saline in a bowl on the sterile field, and injected into the pocket. Patients will also receive postoperative antibiotic prescription to last for 2 days after the procedure. This can be either Cefalexin 500 mg PO TID OR Cephadroxil 1000 mg BID. Penicillin-allergic patients will receive Clindamycin 150-300 mg TID

    Number of subjects in period 1
    		Conventional arm Incremental therapy
    Started
    9627
    9976
    Device implantation
    9627
    9976
    Completed
    9605
    9954
    Not completed
    22
    22
         Lost to follow-up
    22
    22

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Randomisation
    Reporting group description
    		 -

    Reporting group values
    		 Randomisation Total
    Number of subjects
    		 19603 19603
    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
    72.0 +/- 13.1
    Units: years
        arithmetic mean (standard deviation)
    		 72.0 ( 13.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6652 6652
        Male
    		 12951 12951

    End points

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    End points reporting groups
    Reporting group title
    Conventional arm
    Reporting group description
    		 -

    Reporting group title
    Incremental therapy
    Reporting group description
    		 -

    Primary: hospitalisation attributed to device infection

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    End point title
    		 hospitalisation attributed to device infection [1]
    End point description
    End point type
    Primary
    End point timeframe
    12 months post procedure
    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: See publication for more statistical details. Link is added in more information tab
    End point values
    		 Conventional arm Incremental therapy
    Number of subjects analysed
    77
    66
    Units: patients
    77
    66
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    12 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 N/A
    Dictionary version
    N/A
    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: See publication for more Adverse event details. Link is added in more information tab

    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/30545448
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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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