Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-04 @ 4:41 PM
Study NCT ID:
NCT05007158
Status:
COMPLETED
Last Update Posted:
2022-05-03
First Post:
2021-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Procalcitonin as a Biomarker Diagnosing CDI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-02', 'studyFirstSubmitDate': '2021-07-31', 'studyFirstSubmitQcDate': '2021-08-10', 'lastUpdatePostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diagnostic value of PCT', 'timeFrame': 'pre-intervention/procedure/surgery. i.e. at the time of CIED explantation. Measurement of PCT as an biomarker revealing the acute infection (like a sepsis marker)', 'description': 'diagnostic value of PCT in differentiating local pocket infection from infection-free controls and calculated the sensitivity and specificity of the pre-established cut-off value of 0.05 ng/ml'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Implantable Electronic Device Infections']}, 'descriptionModule': {'briefSummary': 'Cardiac device infections (CDI), especially pocket infections, are difficult to be diagnosed. Device pocket infections are not associated with elevated white blood cell count. CRP is only assoziated with a low sensitivity. The diagnosis of a local pocket infection is challenging and relies primarily on the clinical presentation. The prospective DIRT study identified procalcitonin (PCT) among 14 biomarkers as the most promising biomarker to aid the diagnosis of pocket infection.\n\nThe study aims to validate the proposed PCT cut-off value of 0.05 ng/ml for the diagnosis of pocket infection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients presenting with cardiac device infection CDI', 'eligibilityCriteria': 'Inclusion Criteria:\n\n• device associated infections\n\nExclusion Criteria:\n\n* malignancy\n* cytostatic or immunomodulating therapy'}, 'identificationModule': {'nctId': 'NCT05007158', 'acronym': '(DIRT II)', 'briefTitle': 'Validation of Procalcitonin as a Biomarker Diagnosing CDI', 'organization': {'class': 'OTHER', 'fullName': 'Deutsches Herzzentrum Muenchen'}, 'officialTitle': 'A Prospective Case-control Validation of Procalcitonin as a Biomarker Diagnosing Pacemaker and Implantable Cardioverter Defibrillator Pocket Infection', 'orgStudyIdInfo': {'id': 'GER-EP-023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pocket infection', 'description': 'Patients with isolated pocket infection were diagnosed in the presence of local signs of inflammation (one or more of erythema, pain, warmth, swelling, induration, tenderness, or fluctuation), wound dehiscence, hardware protrusion or pus discharge at the pocket in the absence of systemic findings.', 'interventionNames': ['Other: procalcitonin blood test']}, {'label': 'CIED systemic infection', 'description': 'Patient s with a CIED systemic infection, diagnosed as the presence of pocket infection accompanied by bacteraemia or echocardiographic finding suggestive of infective endocarditis, but not fulfilling the Duke criteria.', 'interventionNames': ['Other: procalcitonin blood test']}, {'label': 'Lead-associated infective endocarditis', 'description': 'Patients with infective endocarditis, diagnosed according to modified Duke criteria', 'interventionNames': ['Other: procalcitonin blood test']}, {'label': 'control group', 'description': 'CIED Patients presenting for elective device exchange or planned lead revision between without local or systemic infections were selected as controls', 'interventionNames': ['Other: procalcitonin blood test']}], 'interventions': [{'name': 'procalcitonin blood test', 'type': 'OTHER', 'description': 'blood samples of all participants were analyzed for procalitonin levels, using a commercially available procalitonin testing kit', 'armGroupLabels': ['CIED systemic infection', 'Lead-associated infective endocarditis', 'control group', 'pocket infection']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deutsches Herzzentrum Muenchen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}