CIED Infection Quality Initiative Demonstration Project
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:
🦠 Infections
🗓️ Study Start (Actual) 10 May 2023
🗓️ Primary Completion (Estimated) 31 August 2024
✅ Study Completion (Estimated) 31 August 2024
👥 Enrollment (Estimated) 200
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Chicago, Illinois, United States
📍 Charlotte, North Carolina, United States
📍 Greensboro, North Carolina, United States

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 21 July 2022
  • First Submitted that Met QC Criteria 21 July 2022
  • First Posted 25 July 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 February 2024
  • Last Update Posted 20 February 2024
  • Last Verified February 2024