CIED Infection Quality Initiative Demonstration Project
Recruiting now · Not applicable
Conditions studied: Infections
In brief
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.
Key facts
- Study ID
- NCT05471973
- Run by
- Duke University
- People needed
- 200
- Starts
- 2023-05-10
- Expected to finish
- 2027-03-31
- Last updated by the study team
- 2026-05-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years
- Cardiovascular Implantable Electronic Device (CIED) in place
- Presumed CIED infection, as defined by:
- 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
- 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
You may not qualify if…
- 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)
Where it is running
- Northwestern — Chicago, Illinois, United States (enrolling)
- Atrium Health — Charlotte, North Carolina, United States
- Moses Cone — Greensboro, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.