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

Sponsor
Deutsches Herzzentrum Muenchen (Other)
Overall Status
Completed
CT.gov ID
NCT01619267
Collaborator
University Hospital Dubrava (Other)
103
Enrollment
4
Locations
15
Duration (Months)
25.8
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Jan 1, 2012
    Actual Primary Completion Date :
    Mar 1, 2013
    Actual Study Completion Date :
    Apr 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    device associated infection

    patients with proven device associated infection
    control group

    patients without device associated infection

    Outcome Measures

    Primary Outcome Measures

    1. procalcitonine [no follow-up]

      procalcitonine is determined at inclusion and correlated to infectíon status

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • device associated infections
    Exclusion Criteria:

    • malignancy

    • cytostatic or immunomodulating therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Dubrava Zagreb Croatia
    2 Krankenhaus Landshut-Achdorf Landshut Germany
    3 Deutsches Herzzentrum München Germany
    4 Ospedale San Pietro FBF Rome Italy

    Sponsors and Collaborators

    • Deutsches Herzzentrum Muenchen
    • University Hospital Dubrava

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Deutsches Herzzentrum Muenchen
    ClinicalTrials.gov Identifier:
    NCT01619267
    Other Study ID Numbers:
    • GER-EP-008
    First Posted:
    Jun 14, 2012
    Last Update Posted:
    Apr 10, 2017
    Last Verified:
    Apr 1, 2017
    Keywords provided by Deutsches Herzzentrum Muenchen
    pacemaker defibrillator infection
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases

    Study Results

    No Results Posted as of Apr 10, 2017