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

April 7, 2017 updated by: Deutsches Herzzentrum Muenchen

Device Associated Infections - Role of New Diagnostic Tools

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia
        • University Hospital Dubrava
  • Germany
      • Landshut, Germany
        • Krankenhaus Landshut-Achdorf
      • München, Germany
        • Deutsches Herzzentrum
  • Italy
      • Rome, Italy
        • Ospedale San Pietro FBF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive patients presenting with device associated infections

Description

Inclusion Criteria:

  • device associated infections

Exclusion Criteria:

  • malignancy
  • cytostatic or immunomodulating therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
device associated infection
patients with proven device associated infection
control group
patients without device associated infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
procalcitonine
Time Frame: no follow-up
procalcitonine is determined at inclusion and correlated to infectíon status
no follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

University Hospital Dubrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

June 11, 2012

First Submitted That Met QC Criteria

June 12, 2012

First Posted (Estimate)

June 14, 2012

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GER-EP-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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