Clinical Trial Results:
A Cluster Crossover Trial Comparing Conventionl vs Incremental Antibiotic Therapy for the Prevention or Arrhytmia Device Infection
Summary
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EudraCT number |
2014-000459-10 |
Trial protocol |
NL |
Global end of trial date |
08 Sep 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Jul 2021
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First version publication date |
30 Jul 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
PADIT
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01628666 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Canadian Institutes of Health Research
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Sponsor organisation address |
160 Elgin Street, 10th Floor , Ottawa, Canada, 4809A
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Public contact |
Marco Alings, Werkgroep Cardiologische Centra Nederland, +31 76595 4166, marco@alings.org
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Scientific contact |
Marco Alings, Werkgroep Cardiologische Centra Nederland, +31 76595 4166, marco@alings.org
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
18 Oct 2018
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
08 Sep 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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Protection of trial subjects |
Standard non-antibiotic operating procedures to reduce infection will be continued in each centre.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
17 Dec 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Canada: 18893
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Country: Number of subjects enrolled |
Netherlands: 710
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Worldwide total number of subjects |
19603
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EEA total number of subjects |
710
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
19603
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients were recruited in 28 centers. 24 centers in Canada and 4 centers in the Netherlands. | ||||||||||||||||||
Pre-assignment
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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
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Period 1 title |
Randomisation (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||
Blinding implementation details |
Both patient and operator were aware of the open-label treatment. Design was cluster randomisation.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Conventional arm | ||||||||||||||||||
Arm description |
- | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
Cefazolin/Vancomycin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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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.
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Arm title
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Incremental therapy | ||||||||||||||||||
Arm description |
- | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
Bacitracin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for injection
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Routes of administration |
Topical use
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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
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Baseline characteristics reporting groups
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Reporting group title |
Randomisation
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Conventional arm
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Reporting group description |
- | ||
Reporting group title |
Incremental therapy
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Reporting group description |
- |
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End point title |
hospitalisation attributed to device infection [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
12 months post procedure
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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 |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
12 months
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
N/A | ||
Dictionary version |
N/A
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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 |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/30545448 |