Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-02-26 @ 6:52 AM
Study NCT ID:
NCT04756895
Status:
COMPLETED
Last Update Posted:
2021-09-10
First Post:
2021-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vancomycin Dose Adjustments Comparing Trough Levels to The AUC/MIC Method Using a Bayesian Approach in a Hospitalized Adult Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-09', 'studyFirstSubmitDate': '2021-02-08', 'studyFirstSubmitQcDate': '2021-02-15', 'lastUpdatePostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validation of The Research Protocol', 'timeFrame': 'Through study completion, an average of 2 weeks', 'description': 'Evaluation of adhesion rate to the sampling protocol of 80% or more and adhesion rate to software recommendations of 90% or more'}, {'measure': 'Evaluation of Recruitment', 'timeFrame': 'Baseline', 'description': 'Evaluation of consent rate of 30% or more and the number of patients recruited per month of 10 or more'}], 'secondaryOutcomes': [{'measure': 'The proportion of patients who reach a therapeutic level in the first 48 hours', 'timeFrame': 'At 48 hours after the first dose of vancomycin', 'description': 'Percentage of patients who reach a therapeutic level in the first 48 hours'}, {'measure': 'Time to reach the vancomycin target', 'timeFrame': 'During the vancomycin treatment', 'description': 'Number of hours necessary to reach the vancomycin target. Number of hours will be classified in the following categories: 24-48 hours, 49-96 hours, 97 hours and above.'}, {'measure': 'The number of adjustments required to reach the vancomycin target', 'timeFrame': 'During the vancomycin treatment', 'description': 'Number of dose adjustments required to reach the vancomycin target'}, {'measure': 'The number of vancomycin dosage level monitoring to reach the vancomycin target', 'timeFrame': 'During the vancomycin treatment', 'description': 'The number of vancomycin dosage level monitoring to reach the vancomycin target'}, {'measure': 'The proportion of vancomycin dosage level monitoring in the vancomycin target', 'timeFrame': 'During the vancomycin treatment', 'description': 'Percentage of vancomycin dosage level monitoring in the vancomycin target'}, {'measure': 'The difference between the AUC calculated by the Bayesian method and the trapezoid method', 'timeFrame': 'During the vancomycin treatment', 'description': 'Difference in percentage of the vancomycin AUC calculated by the Bayesian method and the trapezoid method'}, {'measure': 'The difference between the initial prescribed dose and the dose suggested by the Bayesian software.', 'timeFrame': 'Baseline', 'description': 'Difference in percentage of the initial prescribed dose and the dose suggested by the Bayesian software.'}, {'measure': 'Proportion of acute kidney injury', 'timeFrame': 'During the vancomycin treatment', 'description': 'Percentage of acute kidney injury.'}, {'measure': 'Average daily dose of vancomycin', 'timeFrame': 'Through study completion, an average of 2 weeks', 'description': 'Average of the daily dose of vancomycin calculated in mg per kg of total body weight'}, {'measure': 'Operational Impact', 'timeFrame': 'Immediately after the intervention', 'description': "Evaluation of the impact on pharmacist's time required for monitoring vancomycin"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bayesian approach', 'Dose adjustments', 'trough'], 'conditions': ['Vancomycin', 'Adult', 'Area Under Curve']}, 'descriptionModule': {'briefSummary': 'This pilot study is a prospective, randomized, controlled, open-label trial to assess the feasibility of a randomized controlled trial of sufficient quality that would assess the efficacy and safety of vancomycin adjustments according to Area under the curve/Minimal inhibitory concentration (AUC0-24h/MIC) calculated by the Bayesian approach rather than by a trough dosage. Randomization will be stratified according to infection severity. Approximately 60 subjects meeting all inclusion and no exclusion criteria will be randomized to have pharmacists perform vancomycin dose adjustments with AUC0-24h / MIC calculated by the Bayesian approach versus the trough dosage approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age;\n* Hospitalized patients\n* Suspected or confirmed infection;\n* Anticipated IV vancomycin treatment for 24 hours or more.\n\nExclusion Criteria:\n\n* Patients with renal replacement therapy (peritoneal dialysis, continuous renal replacement therapy or hemodialysis);\n* Treatment of vancomycin in continuous infusion;'}, 'identificationModule': {'nctId': 'NCT04756895', 'acronym': 'VancoDATABayes', 'briefTitle': 'Vancomycin Dose Adjustments Comparing Trough Levels to The AUC/MIC Method Using a Bayesian Approach in a Hospitalized Adult Population', 'organization': {'class': 'OTHER', 'fullName': 'CR-CSSS Champlain-Charles-Le Moyne'}, 'officialTitle': 'Vancomycin Dose Adjustments Comparing Trough Levels to The AUC0-24h/MIC Method Using a Bayesian Approach in a Hospitalized Adult Population: A Pilot Study', 'orgStudyIdInfo': {'id': '2021-600'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bayesian method', 'description': 'Pharmacists will perform vancomycin dose adjustments according to AUC0-24h/MIC using the Bayesian method with a web application', 'interventionNames': ['Other: Vancomycin dose adjustment using the Bayesian method']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard method', 'description': 'Pharmacists will perform vancomycin dose adjustments according to trough levels of vancomycin.', 'interventionNames': ['Other: Vancomycin dose adjustment using the trough level method']}], 'interventions': [{'name': 'Vancomycin dose adjustment using the Bayesian method', 'type': 'OTHER', 'description': 'This intervention is the experimental method. The AUC/MIC target is 400-600 mg\\*hour/L.', 'armGroupLabels': ['Bayesian method']}, {'name': 'Vancomycin dose adjustment using the trough level method', 'type': 'OTHER', 'description': 'This intervention is the standard method. Previous clinical guidelines recommended this method. The trough target is 10-15 mg/L for non-severe infections and 15-20 mg/L for severe infections.', 'armGroupLabels': ['Standard method']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J4V 2H1', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Charles-Le Moyne Hospital', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}], 'overallOfficials': [{'name': 'Benoît Crevier, PharmD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles-Le Moyne Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CR-CSSS Champlain-Charles-Le Moyne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Benoit Crevier', 'investigatorAffiliation': 'CR-CSSS Champlain-Charles-Le Moyne'}}}}