Role of New Diagnostic Tool in Device (ICD / PM) Associated Infections (DIRT)
This study is currently recruiting participants.
Verified February 2013 by Deutsches Herzzentrum Muenchen
Sponsor:
Deutsches Herzzentrum Muenchen
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: February 28, 2013
Last verified: February 2013
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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
| Estimated Enrollment: | 125 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619267
Locations
| Croatia | |
| University Hospital Dubrava | Recruiting |
| Zagreb, Croatia | |
| Contact: Hrvoje Vrazic, PhD 00385 1 29-02-444 | |
| Germany | |
| Krankenhaus Landshut-Achdorf | Recruiting |
| Landshut, Germany | |
| Contact: Bernard Zrenner, PhD 00498714040 | |
| Deutsches Herzzentrum | Recruiting |
| München, Germany | |
| Contact: Christof Kolb, PhD 00498912182020 | |
| Sub-Investigator: Carsten Lennerz, MD | |
| Italy | |
| Ospedale San Pietro FBF | Not yet recruiting |
| Rome, Italy | |
| Contact: D Porcelli, MD 00 39 06 33581 | |
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: | February 28, 2013 |
| Health Authority: | Germany: Ethics board of TU München |
Keywords provided by Deutsches Herzzentrum Muenchen:
|
pacemaker defibrillator infection |
ClinicalTrials.gov processed this record on May 21, 2013