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Clinical Trials/NCT01619267
NCT01619267
Completed
Not Applicable

Device Associated Infections - Role of New Diagnostic Tools

Deutsches Herzzentrum Muenchen4 sites in 3 countries103 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Biomarkers in Device Associated Infections
Sponsor
Deutsches Herzzentrum Muenchen
Enrollment
103
Locations
4
Primary Endpoint
procalcitonine
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Infections related to implantable pacemakers or cardioverters defibrillators are sometimes difficult to be diagnosed. Diificulties in the diagnosis include a low sensitivity of standard markers of inflammation such as C-reactive protein or white blood cell count and the diagnosis is mainly based on the clinical presentation. The observational DIRT-study evaluates if new biomarkers may be more suitable to support a diagnosis of device associated infections than the currently available ones.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
April 2013
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Deutsches Herzzentrum Muenchen
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • device associated infections

Exclusion Criteria

  • malignancy
  • cytostatic or immunomodulating therapy

Outcomes

Primary Outcomes

procalcitonine

Time Frame: no follow-up

procalcitonine is determined at inclusion and correlated to infectíon status

Study Sites (4)

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