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

Biomarkers in Device Associated Infections Clinical Trial

— DIRT  

Official title:

Device Associated Infections - Role of New Diagnostic Tools

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01619267
• Other study ID #: GER-EP-008
• Status: Completed
• Phase: N/A
• First received: June 11, 2012
• Last updated: April 7, 2017
• Start date: January 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2017
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• device associated infections

Exclusion Criteria:

• malignancy

• cytostatic or immunomodulating therapy

Related Conditions & MeSH terms

• Biomarkers in Device Associated Infections
• Communicable Diseases
• Infection

Locations

Country	Name	City	State
Croatia	University Hospital Dubrava	Zagreb
Germany	Krankenhaus Landshut-Achdorf	Landshut
Germany	Deutsches Herzzentrum	München
Italy	Ospedale San Pietro FBF	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen	University Hospital Dubrava

Countries where clinical trial is conducted

Croatia,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	procalcitonine	procalcitonine is determined at inclusion and correlated to infectíon status	no follow-up

External Links

•   Publication DIRT-Study