Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-02-05 @ 9:12 PM
Study NCT ID:
NCT02844192
Status:
UNKNOWN
Last Update Posted:
2016-07-26
First Post:
2016-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Vancomycin in ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-21', 'studyFirstSubmitDate': '2016-07-12', 'studyFirstSubmitQcDate': '2016-07-21', 'lastUpdatePostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Akaike information criterion as a measurement of goodness of fit of pharmacokinetic modeling of vancomycin serum concentration', 'timeFrame': 'week 1', 'description': 'All available vancomycin measurements during the first week of treatment will be included in the pharmacokinetics model.\n\nAll vancomycin dosages up to seven days of treatment will be used in a population pharmacokinetic model and an individual pharmacokinetic model'}], 'secondaryOutcomes': [{'measure': 'Rate of patients with under-dosage of vancomycin at day 2 of treatment', 'timeFrame': 'day 2', 'description': 'under-dosage of vancomycin is defined by a vancomycin serum concentration below 15 mg/l on day 2 of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vancomycin', 'under dosage', 'intensive care unit', 'pharmacokinetics'], 'conditions': ['Suspected Infection With Vancomycin Susceptible Bacterial Strains']}, 'descriptionModule': {'briefSummary': 'Vancomycin is frequently under-dosed in ICU patients during the first 24-48 hours of treatment. Glomerular hyperfiltration syndrome, increased drug volume of distribution, vasopressor use, male sex and hypoalbuminemia are identified risk factor for vancomycin underdosing in ICU patients, among others.\n\nTo date, bedside estimation of vancomycin volume of distribution is challenging, and new methods for optimizing drug administration are required.\n\nThe Picco device is a moderately invasive hemodynamic monitoring system, providing parameters that may help estimation of vancomycin pharmacokinetics parameter.\n\nThe aim of this study is to test whether addition of hemodynamic parameters would improve pharmacokinetics modelling of vancomycin concentration in ICU patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ICU patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient hospitalized in intensive care unit\n* under intravenous vancomycin started during current ICU hospitalization\n* with at least one vancomycin serum concentration available\n* under hemodynamic monitoring with the Picco ® device\n\nExclusion Criteria:\n\n* vancomycin treatment for less than 24 hours\n* vancomycin concentration in serum unavailable\n* rare comorbidities influencing vancomycin pharmacokinetics\n\n * myeloma\n * cystic fibrosis\n * burn injury on more than 20 % of the body surface\n* previous inclusion in present study'}, 'identificationModule': {'nctId': 'NCT02844192', 'acronym': 'PK-VANCO-ICU', 'briefTitle': 'Pharmacokinetics of Vancomycin in ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Pharmacokinetics of Vancomycin in ICU Patients', 'orgStudyIdInfo': {'id': '69HCL16_0452'}}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon - Hôpital de la Croix-Rousse - Réanimation, Surveillance Continue Médicales et Assistance Respiratoire,103 Grande Rue de la Croix-Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Jean-Christophe RICHARD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}