Biomarkers in Device Associated InfectionsDIRTNCT01619267
Role of New Diagnostic Tool in Device (ICD / PM) Associated Infections
An observational study of Biomarkers in Device Associated Infections, run by Deutsches Herzzentrum Muenchen at 4 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biomarkers in Device Associated Infections
- How many people
- 103 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jan 2012to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients presenting with device associated infections
Who may be able to join
- device associated infections
Who cannot join
- malignancy
- cytostatic or immunomodulating therapy
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
Krankenhaus Landshut-Achdorf
Landshut
Deutsches Herzzentrum
München
About this study
Official title: 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.
- Keywords
- pacemaker defibrillator infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| device associated infection | patients with proven device associated infection | |
| control group | patients without device associated infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
procalcitonine
procalcitonine is determined at inclusion and correlated to infectíon status
Measured: no follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biomarkers in Device Associated InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Dubrava
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619267
- Sponsor's protocol ID
- GER-EP-008
- Acronym
- DIRT
- Status last verified
- Apr 2017
- First submitted
- 11 Jun 2012
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28264059
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Device Associated Infections - Role of New Diagnostic Tools
- ClinicalTrials.gov ID
- NCT01619267
- Acronym / sponsor ID
- DIRT / GER-EP-008
- Keywords
- pacemaker defibrillator infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Collaborators
- University Hospital Dubrava
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 14 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| device associated infection | – | –patients with proven device associated infection |
| control group | – | –patients without device associated infection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients presenting with device associated infections
Key inclusion criteria (1 listed)
- device associated infections
Key exclusion criteria (2 listed)
- malignancy
- cytostatic or immunomodulating therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
procalcitonine
Time frame: no follow-up
procalcitonine is determined at inclusion and correlated to infectíon status
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Derived from this study: PubMed 28264059Lennerz 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.
- Publication DIRT-StudyLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biomarkers in Device Associated Infections, run by Deutsches Herzzentrum Muenchen at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Croatia, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
procalcitonine (time frame: no follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01619267, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.