Validation of Procalcitonin as a Biomarker Diagnosing CDI ((DIRT II))

A Prospective Case-control Validation of Procalcitonin as a Biomarker Diagnosing Pacemaker and Implantable Cardioverter Defibrillator Pocket Infection

Cardiac device infections (CDI), especially pocket infections, are difficult to be diagnosed. Device pocket infections are not associated with elevated white blood cell count. CRP is only assoziated with a low sensitivity. The diagnosis of a local pocket infection is challenging and relies primarily on the clinical presentation. The prospective DIRT study identified procalcitonin (PCT) among 14 biomarkers as the most promising biomarker to aid the diagnosis of pocket infection.

The study aims to validate the proposed PCT cut-off value of 0.05 ng/ml for the diagnosis of pocket infection

Study Overview

• Status: Completed
• Conditions: Cardiac Implantable Electronic Device Infections
• Intervention / Treatment: Other: procalcitonin blood test

• Study Type: Observational
• Enrollment (Anticipated): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients presenting with cardiac device infection CDI

Description

Inclusion Criteria:

• device associated infections

Exclusion Criteria:

• malignancy
• cytostatic or immunomodulating therapy

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pocket infection; Patients with isolated pocket infection were diagnosed in the presence of local signs of inflammation (one or more of erythema, pain, warmth, swelling, induration, tenderness, or fluctuation), wound dehiscence, hardware protrusion or pus discharge at the pocket in the absence of systemic findings.	Other: procalcitonin blood test; blood samples of all participants were analyzed for procalitonin levels, using a commercially available procalitonin testing kit
CIED systemic infection; Patient s with a CIED systemic infection, diagnosed as the presence of pocket infection accompanied by bacteraemia or echocardiographic finding suggestive of infective endocarditis, but not fulfilling the Duke criteria.	Other: procalcitonin blood test; blood samples of all participants were analyzed for procalitonin levels, using a commercially available procalitonin testing kit
Lead-associated infective endocarditis; Patients with infective endocarditis, diagnosed according to modified Duke criteria	Other: procalcitonin blood test; blood samples of all participants were analyzed for procalitonin levels, using a commercially available procalitonin testing kit
control group; CIED Patients presenting for elective device exchange or planned lead revision between without local or systemic infections were selected as controls	Other: procalcitonin blood test; blood samples of all participants were analyzed for procalitonin levels, using a commercially available procalitonin testing kit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic value of PCT	diagnostic value of PCT in differentiating local pocket infection from infection-free controls and calculated the sensitivity and specificity of the pre-established cut-off value of 0.05 ng/ml	pre-intervention/procedure/surgery. i.e. at the time of CIED explantation. Measurement of PCT as an biomarker revealing the acute infection (like a sepsis marker)

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2011
• Primary Completion (Actual): October 10, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: July 31, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: GER-EP-023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No