Treatment for Infections

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Atrium Health, Charlotte, NC
Infections+1 More
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Infections

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 10 Secondary · Reporting Duration: Up to 12 months

Up to 12 months
Days of antibiotic treatments
Estimated healthcare utilization/costs
Length of stay
Mortality
Number of actual extractions
Number of patients identified with suspected CIED infection
Number of patients referred to both Extraction Center (from outside hospital) and electrophysiologists (at Extraction Center) for extraction
Number of patients with multi-organ failure or septic shock at time of extraction
Patient satisfaction as measured by a qualitative survey
Proportion of patients with CIEDs and definite pocket infections who receive extraction (per guidelines)
Proportion of patients with CIEDs and positive blood cultures who receive extraction (per guidelines)
Proportion of patients with extraction during index hospitalization
Proportion of patients with extraction within 7 days of diagnosis
Staff satisfaction as measured by a qualitative survey
Time from positive blood culture/clear pocket infection to extraction for those undergoing extraction

Trial Safety

Safety Progress

1 of 3

Trial Design

0 Treatment Group

200 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months
Closest Location: Atrium Health · Charlotte, NC
Photo of charlotte 1Photo of charlotte 2Photo of charlotte 3
2022First Recorded Clinical Trial
3 TrialsResearching Infections
18 CompletedClinical Trials

Who is running the clinical trial?

Duke Clinical Research InstituteOTHER
57 Previous Clinical Trials
231,117 Total Patients Enrolled
1 Trials studying Infections
42 Patients Enrolled for Infections
Duke UniversityLead Sponsor
2,136 Previous Clinical Trials
3,197,313 Total Patients Enrolled
26 Trials studying Infections
56,755 Patients Enrolled for Infections
Philips HealthcareIndustry Sponsor
116 Previous Clinical Trials
278,128 Total Patients Enrolled
Sean Pokorney, MDPrincipal InvestigatorDuke Clinical Research Institute
Chris Granger, MDPrincipal InvestigatorDuke Clinical Research Institute
1 Previous Clinical Trials
6,268 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a Cardiovascular Implantable Electronic Device (CIED) in place.
You have a positive blood culture for typical skin organisms, or one positive blood culture for all other microorganisms, and 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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.