Role of New Diagnostic Tool in Device (ICD / PM) Associated Infections (DIRT)

This study has been completed.
University Hospital Dubrava
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen Identifier:
First received: June 11, 2012
Last updated: July 3, 2013
Last verified: July 2013
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.

Biomarkers in Device Associated Infections

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Device Associated Infections - Role of New Diagnostic Tools

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • procalcitonine [ Time Frame: no follow-up ] [ Designated as safety issue: No ]
    procalcitonine is determined at inclusion and correlated to infectíon status

Biospecimen Retention:   Samples Without DNA
new inflammatory biomarkers such as procalcitonine

Enrollment: 103
Study Start Date: January 2012
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
device associated infection
patients with proven device associated infection
control group
patients without device associated infection


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients presenting with device associated infections

Inclusion Criteria:

  • device associated infections

Exclusion Criteria:

  • malignancy
  • cytostatic or immunomodulating therapy
  Contacts and Locations
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Please refer to this study by its identifier: NCT01619267

University Hospital Dubrava
Zagreb, Croatia
Krankenhaus Landshut-Achdorf
Landshut, Germany
Deutsches Herzzentrum
München, Germany
Ospedale San Pietro FBF
Rome, Italy
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
University Hospital Dubrava
  More Information

No publications provided

Responsible Party: Deutsches Herzzentrum Muenchen Identifier: NCT01619267     History of Changes
Other Study ID Numbers: GER-EP-008
Study First Received: June 11, 2012
Last Updated: July 3, 2013
Health Authority: Germany: Ethics board of TU München

Keywords provided by Deutsches Herzzentrum Muenchen:
pacemaker defibrillator infection

Additional relevant MeSH terms:
Communicable Diseases
Infection processed this record on December 01, 2015