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

This study has been completed.
Sponsor:
Collaborator:
University Hospital Dubrava Zagreb Croatia
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01619267
First received: June 11, 2012
Last updated: July 3, 2013
Last verified: July 2013
  Purpose

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
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)
Groups/Cohorts
device associated infection
patients with proven device associated infection
control group
patients without device associated infection

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Consecutive patients presenting with device associated infections

Criteria

Inclusion Criteria:

  • device associated infections

Exclusion Criteria:

  • malignancy
  • cytostatic or immunomodulating therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619267

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

No publications provided

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on August 01, 2014