Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-03-26 @ 9:42 PM
Study NCT ID:
NCT01995760
Status:
COMPLETED
Last Update Posted:
2014-09-04
First Post:
2013-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Most Appropriate Parameter Correlates With Clinical Effectiveness of Vancomycin: Trough Drug Concentration or Area Under Curve (AUC)/Minimum Inhibitory Concentration (MIC)?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-02', 'studyFirstSubmitDate': '2013-11-10', 'studyFirstSubmitQcDate': '2013-11-26', 'lastUpdatePostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day mortality', 'timeFrame': 'Day 30 after index date (the date of positive methicillin-resistant Staphylococcus aureus blood culture)'}], 'secondaryOutcomes': [{'measure': '90-day mortality', 'timeFrame': 'Day 90 after index date (the date of positive methicillin-resistant Staphylococcus aureus blood culture)'}, {'measure': 'In-hospital mortality', 'timeFrame': 'Discharge day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vancomycin', 'therapeutic response monitoring', 'AUC/MIC'], 'conditions': ['Methicillin-resistant Staphylococcus Aureus Septicemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate which is the most appropriate parameter correlates with clinical effectiveness of vancomycin: trough drug level or AUC/MIC.', 'detailedDescription': "Several studies have shown AUC/MIC to be the better pharmacokinetic-pharmacodynamic parameter for clinical effectiveness of vancomycin. However, the 2009 consensus guideline for vancomycin therapeutic monitoring continued to recommend trough serum concentration monitoring in the clinical setting. In 2011, Patel et al showed that highly difference between AUC(72-96h) and Cmin(96h). Different dosing and creatinine clearance may reach the same trough drug level with different AUC. The investigators wonder whether trough drug level can serve as a substitute marker for AUC and as a parameter for vancomycin therapeutic monitoring.\n\nIn this study, the investigators will calculate AUC/MIC of vancomycin with published formula, analyze its correlation with patient's clinical outcome and compare that with trough drug level."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inpatients of National Taiwan University Hospital. During the period of 2001/1/1 to 2013/12/31, age above or equal to 20 year-old adult with positive methicillin-resistant Staphylococcus aureus blood culture who receiving vancomycin therapy with therapeutic monitoring.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatients of National Taiwan University Hospital\n* Age above or equal to 20 years old\n* Positive methicillin-resistant Staphylococcus aureus blood culture\n* Receiving vancomycin therapy for definitive use\n* Undergoing therapeutic drug monitoring (had serum vancomycin concentration level)\n\nExclusion Criteria:\n\n* Age below 20 years old\n* Without details of vancomycin dose and frequency\n* Vancomycin treatment shorter than 72 hours\n* Without renal function data (serum creatinine level, creatinine clearance)\n* Without infection-related clinical outcomes (lab data such as white blood cell count , seg, C reactive protein , body temperature records)\n* Receiving renal replacement therapy\n* Therapeutic drug monitoring before reaching steady state\n* With abnormal and undefined serum concentration'}, 'identificationModule': {'nctId': 'NCT01995760', 'briefTitle': 'The Most Appropriate Parameter Correlates With Clinical Effectiveness of Vancomycin: Trough Drug Concentration or Area Under Curve (AUC)/Minimum Inhibitory Concentration (MIC)?', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Most Appropriate Parameter Correlates With Clinical Effectiveness of Vancomycin: Trough Drug Concentration or Area Under Curve (AUC)/Minimum Inhibitory Concentration (MIC)?', 'orgStudyIdInfo': {'id': '201310037RINA'}}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Li-Jiuan Shen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}