Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2026-02-27 @ 12:48 AM
Study NCT ID:
NCT01661361
Status:
UNKNOWN
Last Update Posted:
2012-08-09
First Post:
2012-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimalisation of Therapeutic Drug Monitoring (TDM) of Vancomycin in Patients With Central Venous Port Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055499', 'term': 'Catheter-Related Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089382', 'term': 'Oxygen Saturation'}], 'ancestors': [{'id': 'D008660', 'term': 'Metabolism'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-08', 'studyFirstSubmitDate': '2012-07-20', 'studyFirstSubmitQcDate': '2012-08-08', 'lastUpdatePostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison of central (via port device) and peripherally obtained vancomycin levels: the difference, when using the new flushing technique, is allowed to be maximally 0.5 mg/L', 'timeFrame': 'central and peripheral vancomycin levels will be obtained during steady state: this means starting from the 4th dose (= day 2) of vancomycin treatment. Vancomycin is usually given during 14 days after the last positive blood culture.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vancomycin', 'levels', 'central venous port device', 'peripherally obtained levels', 'dose adjustments', 'TDM'], 'conditions': ['Catheter-related Infection']}, 'descriptionModule': {'briefSummary': 'Recently, it was reported that when vancomycin levels are determined after port sampling, levels can be falsely increased potentially leading to wrong dose adjustments.\n\nThe investigators conducted an in vitro experiment using several central venous port devices, in which different flushing techniques were evaluated yielding residual vancomycin levels of less than 0.5 mg/L.\n\nIn this study, the investigators want to evaluate this flushing technique in vivo in 15 patients admitted with catheter-related infection and treated with systemic vancomycin and vancomycin antibiotic lock.\n\nThe purpose is to assess if correct flushing can avoid spurious vancomycin levels obtained via port sampling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients admitted for catheter related infection with methicillin-resistant coagulase-negative staphylococci (MR-CNS) and treated with systemic vancomycin in combination with vancomycin antibiotic lock via central venous port device.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* adult patients,\n* having central venous port device,\n* treated with systemic vancomycin in combination with vancomycin antibiotic lock\n\nExclusion Criteria:\n\n* pregnant women,\n* children,\n* patients with 'do not resuscitate' (DNR) code"}, 'identificationModule': {'nctId': 'NCT01661361', 'briefTitle': 'Optimalisation of Therapeutic Drug Monitoring (TDM) of Vancomycin in Patients With Central Venous Port Devices', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Optimalisation of Therapeutic Drug Monitoring (TDM) of Vancomycin in Patients With Central Venous Port Devices', 'orgStudyIdInfo': {'id': 'S54585'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'vancomycin cohort', 'interventionNames': ['Procedure: blood levels']}], 'interventions': [{'name': 'blood levels', 'type': 'PROCEDURE', 'armGroupLabels': ['vancomycin cohort']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Isabel Spriet, PharmD PhD', 'role': 'CONTACT', 'email': 'isabel.spriet@uzleuven.be', 'phone': '0032 16 34 30 80'}, {'name': 'Jan Verhaegen, MD PhD', 'role': 'CONTACT', 'email': 'jan.verhaegen@uzleuven.be', 'phone': '0032 16 33 22 11'}], 'overallOfficials': [{'name': 'Isabel Spriet, PharmD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pharmacy Dpt, University Hospitals Leuven'}, {'name': 'Jan Verhaegen, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical Diagnostic Sciences, University Hospitals Leuven'}, {'name': 'Hans Prenen, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Digestive ONcology, University Hosptials Leuven'}, {'name': 'Willy Peetermans, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Internal Medicine, University Hospitals Leuven'}, {'name': 'Ludo Willems, PharmD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pharmacy Dpt., University Hosptials Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PharmD, PhD', 'investigatorFullName': 'Isabelle Spriet', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}