Validation of Procalcitonin as a Biomarker Diagnosing CDI

Cardiac Implantable Electronic Device Infections Clinical Trial

— (DIRT II)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05007158
• Other study ID #: GER-EP-023
• Status: Completed
• Start date: December 1, 2011
• Est. completion date: November 1, 2021

Study information

• Verified date: July 2021
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 1, 2021
• Est. primary completion date: October 10, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• device associated infections

Exclusion Criteria:

• malignancy

• cytostatic or immunomodulating therapy

Related Conditions & MeSH terms

• Cardiac Implantable Electronic Device Infections
• Infections

Intervention

Other:
• procalcitonin blood test
blood samples of all participants were analyzed for procalitonin levels, using a commercially available procalitonin testing kit

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)