Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-02 @ 6:24 PM
Study NCT ID:
NCT01418833
Status:
COMPLETED
Last Update Posted:
2015-02-09
First Post:
2011-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preliminary Experience of Routine Voriconazole Therapeutic Drug Monitoring (TDM) in a Tertiary Care Centre
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-06', 'studyFirstSubmitDate': '2011-08-16', 'studyFirstSubmitQcDate': '2011-08-16', 'lastUpdatePostDateStruct': {'date': '2015-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Voriconazole plasma levels during routine intravenous and oral therapy', 'timeFrame': 'trough levels every 4 days after start or dose adjustment of voriconazole'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['voriconazole', 'therapeutic drug monitoring', 'plasma levels', 'dose adjustment'], 'conditions': ['Patients Treated With Voriconazole']}, 'descriptionModule': {'briefSummary': 'The first goal of this study is to map all the subtherapeutic, therapeutic and supratherapeutic voriconazole plasma levels in the University Hospitals Leuven. The second objective is to optimize and validate guidelines for dose modifications in patients with too low or high plasma concentrations and to investigate if the same guidelines can be used in different patient populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with voriconazole, in whom at least 1 voriconazole plasma level was determined', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated with voriconazole\n* at least 1 voriconazole plasma level measured during therapy\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01418833', 'briefTitle': 'Preliminary Experience of Routine Voriconazole Therapeutic Drug Monitoring (TDM) in a Tertiary Care Centre', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Preliminary Experience of Routine Voriconazole Therapeutic Drug Monitoring (TDM) in a Tertiary Care Centre.', 'orgStudyIdInfo': {'id': 'ML7258'}}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Kim Vanstraelen, R.Ph.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hospital Pharmacist', 'investigatorFullName': 'Ap.r Kim Vanstraelen', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}