Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05471973

CIED Infection Quality Initiative Demonstration Project

Led by Duke University · Updated on 2026-05-06

200

Participants Needed

3

Research Sites

203 weeks

Total Duration

On this page

Sponsors

D

Duke University

Lead Sponsor

D

Duke Clinical Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

CIED Infection Quality Initiative Demonstration Project

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Have a cardiovascular implantable electronic device (CIED) in place
  • Presumed CIED infection defined by either two or more positive blood cultures for typical skin organisms or one positive blood culture for other microorganisms with no other infection source
  • Definite pocket infection signs such as localized redness, swelling, pain, tenderness, warmth, erosion, or drainage, even if cultures are negative due to prior antibiotic treatment
Not Eligible

You will not qualify if you...

  • Patients unsuitable for device extraction, for example those with do-not-attempt-resuscitation orders not on survival-prolonging therapy
  • Death within one week of confirmed CIED systemic infection diagnosis or positive blood culture
  • Patients with bacteremia from sources other than the CIED that resolved without evidence of device infection
  • Patients with left ventricular assist devices (LVADs)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Northwestern

Chicago, Illinois, United States, 60611

Actively Recruiting

2

Atrium Health

Charlotte, North Carolina, United States, 28203

Not Yet Recruiting

3

Moses Cone

Greensboro, North Carolina, United States, 27401

Not Yet Recruiting

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Research Team

K

Kimberly Ward, MPH

CONTACT

S

Sarah Brady

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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