Status:
NOT_YET_RECRUITING
Reduction of Antibiotherapy Duration for Infections on Implantable Extra Cardiac Devices Leads
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Cardiac Devices Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The design is an Open-label randomized controlled multicenter non-inferiority trial with blinded assessor which compares 2 antibiotic strategy: 14-day antibiotic therapy after removal of infected mate...
Detailed Description
Infections of cardiac implantable electronic devices (CIED) are one of the most frequent complication after implantation of these devices, with an incidence rate estimated at 4.82 / 1000 in Denmark, m...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Diagnosis of CIED leads infections, defined by:
- Symptoms/signs of systemic infection AND positive blood cultures fulfilled the major Duke microbiological criteria AND echocardiography consistent with vegetation(s) attached to lead(s) AND/OR \[18F\]FDG PET/CT or radiolabelled WBC SPECT/CT detection of abnormal activity along leads OR
- Symptoms/signs of systemic infection AND NO, signs of generator pocket infection, AND culture, histology or molecular evidence of infection on explanted lead.
- Complete removal of the infected CIED
- Signed informed consent
- French National Health Assurance
Exclusion
- Current involvement of native or prosthetic heart valve
- Distant infectious foci (such as haematogenous vertebral osteomyelitis, pulmonary abscess…) justifying a prolonged duration of therapy.
- Positive blood culture \> 24 hours after cultures despite CIED removal
- CIED infection with Mycobacteria or Fungi
- Women who are pregnant or nursing
- Females of childbearing potential without effective method of birth control
- Patients who are under tutorship or curatorship
Key Trial Info
Start Date :
June 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06203769
Start Date
June 30 2024
End Date
June 30 2028
Last Update
January 12 2024
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