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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01619267
Recruitment Status : Completed
First Posted : June 14, 2012
Last Update Posted : April 10, 2017
University Hospital Dubrava
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

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.

Condition or disease
Biomarkers in Device Associated Infections

Study Type : Observational
Actual Enrollment : 103 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Device Associated Infections - Role of New Diagnostic Tools
Study Start Date : January 2012
Primary Completion Date : March 2013
Study Completion Date : April 2013

device associated infection
patients with proven device associated infection
control group
patients without device associated infection

Primary Outcome Measures :
  1. procalcitonine [ Time Frame: no follow-up ]
    procalcitonine is determined at inclusion and correlated to infectíon status

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Deutsches Herzzentrum Muenchen Identifier: NCT01619267     History of Changes
Other Study ID Numbers: GER-EP-008
First Posted: June 14, 2012    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017

Keywords provided by Deutsches Herzzentrum Muenchen:
pacemaker defibrillator infection

Additional relevant MeSH terms:
Communicable Diseases