Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2026-01-31 @ 12:46 AM
Study NCT ID:
NCT01619267
Status:
COMPLETED
Last Update Posted:
2017-04-10
First Post:
2012-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of New Diagnostic Tool in Device (ICD / PM) Associated Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'new inflammatory biomarkers such as procalcitonine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-07', 'studyFirstSubmitDate': '2012-06-11', 'studyFirstSubmitQcDate': '2012-06-12', 'lastUpdatePostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'procalcitonine', 'timeFrame': 'no follow-up', 'description': 'procalcitonine is determined at inclusion and correlated to infectÃon status'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pacemaker defibrillator infection'], 'conditions': ['Biomarkers in Device Associated Infections']}, 'referencesModule': {'references': [{'pmid': '28264059', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0172384', 'label': 'Publication DIRT-Study'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients presenting with device associated infections', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* device associated infections\n\nExclusion Criteria:\n\n* malignancy\n* cytostatic or immunomodulating therapy'}, 'identificationModule': {'nctId': 'NCT01619267', 'acronym': 'DIRT', 'briefTitle': 'Role of New Diagnostic Tool in Device (ICD / PM) Associated Infections', 'organization': {'class': 'OTHER', 'fullName': 'Deutsches Herzzentrum Muenchen'}, 'officialTitle': 'Device Associated Infections - Role of New Diagnostic Tools', 'orgStudyIdInfo': {'id': 'GER-EP-008'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'device associated infection', 'description': 'patients with proven device associated infection'}, {'label': 'control group', 'description': 'patients without device associated infection'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zagreb', 'country': 'Croatia', 'facility': 'University Hospital Dubrava', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Landshut', 'country': 'Germany', 'facility': 'Krankenhaus Landshut-Achdorf', 'geoPoint': {'lat': 48.52961, 'lon': 12.16179}}, {'city': 'München', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Ospedale San Pietro FBF', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deutsches Herzzentrum Muenchen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Dubrava', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}