NCT05471973 CIED Infection Quality Initiative Demonstration Project
| NCT ID | NCT05471973 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-05-10 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-05-10 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this Quality Initiative (QI) demonstration project is to develop a model to increase guideline-driven care for patients with cardiovascular implantable electronic devices (CIED) infection. Multidisciplinary teams will be established to carry out the multifaceted intervention. This program seeks to improve early identification and diagnosis, appropriate treatment, and faster time to treatment of CIED infection.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years * Cardiovascular Implantable Electronic Device (CIED) in place * Presumed CIED infection, as defined by: 1. Positive blood culture (two or more positive blood cultures for typical skin organisms (coagulase-negative staphylococci, Corynebacterium species, Propionobacterium species), or one positive blood culture for all other microorganisms), with no other source identified to explain the bacteremia 2. Cases with definite evidence of pocket infection (defined as localized erythema, swelling, pain, tenderness, warmth, erosion, or drainage), if treated with antibiotics before culture, even with negative culture, will be considered device infection Exclusion Criteria: * Patients who are inappropriate for device extraction, for example those who are DNAR and not using therapy to prolong survival because any procedure is considered inappropriate and/or it is unlikely that extraction would change overall prognosis * Death within one week of definitive CIED systemic infection diagnosis or positive blood culture. Cases of bacteremia originating from a source other than the CIED that resolve without any evidence of CIED involvement should not be considered as CIED infection * Patients with left ventricular assist devices (LVADs)
Contact & Investigator
Chris Granger, MD
PRINCIPAL INVESTIGATOR
Duke Clinical Research Institute
Frequently Asked Questions
Who can join the NCT05471973 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05471973 currently recruiting?
Yes, NCT05471973 is actively recruiting participants. Contact the research team at kimberly.t.ward@duke.edu for enrollment information.
Where is the NCT05471973 trial being conducted?
This trial is being conducted at Chicago, United States, Charlotte, United States, Greensboro, United States.
Who is sponsoring the NCT05471973 clinical trial?
NCT05471973 is sponsored by Duke University. The principal investigator is Chris Granger, MD at Duke Clinical Research Institute. The trial plans to enroll 200 participants.