A cluster Crossover Trial Comparing Conventionl vs Incremental Antibiotic Therapy for the Prevention or Arrhytmia Device Infection

A cluster Crossover Trial Comparing Conventionl vs Incremental Antibiotic Therapy for the Prevention or Arrhytmia Device Infection - PADIT Cluster Crossover Protocol

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000459-10-NL

Enrollment

10800

Registered

2014-04-03

Start date

2014-06-10

Completion date

Unknown

Last updated

2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

high-risk patients undergoing arrhythmia device procedures MedDRA version: 16.1 Level: PT Classification code 10003119 Term: Arrhythmia System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: Cefazolin Product Code: Cefazolin Pharmaceutical Form: Powder and solution for solution for injection INN or Proposed INN: CEFAZOLIN CAS Number: 25953-19-9 Current Sponsor code: NA Other

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age > 18 years 2. Received one of the following procedures: a) A second or subsequent procedure on the arrhythmia device pocket: i. ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement ii. Pocket or lead revision iii. System upgrade (insertion or attempted insertion of leads) b) New cardiac resynchronization therapy device implant (pacemaker or ICD) 3. Patient NOT known to have device infection at the time of surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5400

Exclusion criteria

Exclusion criteria: NA

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: NA;Primary end point(s): Hospitalization attributed to device infection.;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: NA;Primary end point(s): Hospitalization attributed to device infection.;Timepoint(s) of evaluation of this end point: 12 months

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 12 months;Secondary end point(s): 1. Proven device infection not requiring surgical intervention (medically treated device infection). 2. Any treatment with antibiotics for suspected device infection. 3. Antibiotic-related adverse events including culture or antigen proven C. difficile infection. 4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy. 5. Cost benefit analysis. 6. Rate of device/lead extraction 12 months post patient’s procedure (regardless of the cause).	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 12 months;Secondary end point(s): 1. Proven device infection not requiring surgical intervention (medically treated device infection). 2. Any treatment with antibiotics for suspected device infection. 3. Antibiotic-related adverse events including culture or antigen proven C. difficile infection. 4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy. 5. Cost benefit analysis. 6. Rate of device/lead extraction 12 months post patient’s procedure (regardless of the cause).

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Countries

Canada, Netherlands

Contacts

Public ContactMarco Alings

Werkgroep Cardiologische Centra Nederland

marco@alings.org+3176595 4166

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026