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

NCT ID: NCT01619267

Last Updated: 2017-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Biomarkers in Device Associated Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

device associated infection

patients with proven device associated infection

No interventions assigned to this group

control group

patients without device associated infection

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* device associated infections

Exclusion Criteria

* malignancy
* cytostatic or immunomodulating therapy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital Dubrava

OTHER

Sponsor Role collaborator

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Dubrava

Zagreb, , Croatia

Site Status

Krankenhaus Landshut-Achdorf

Landshut, , Germany

Site Status

Deutsches Herzzentrum

München, , Germany

Site Status

Ospedale San Pietro FBF

Rome, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Croatia Germany Italy

References

Explore related publications, articles, or registry entries linked to this study.

Lennerz C, Vrazic H, Haller B, Braun S, Petzold T, Ott I, Lennerz A, Michel J, Blazek P, Deisenhofer I, Whittaker P, Kolb C. Biomarker-based diagnosis of pacemaker and implantable cardioverter defibrillator pocket infections: A prospective, multicentre, case-control evaluation. PLoS One. 2017 Mar 6;12(3):e0172384. doi: 10.1371/journal.pone.0172384. eCollection 2017.

Reference Type DERIVED
PMID: 28264059 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GER-EP-008

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.