Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-27 @ 9:09 AM
Study NCT ID:
NCT02446392
Status:
COMPLETED
Last Update Posted:
2016-03-03
First Post:
2015-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Distribution of Plasma Drug Concentrations of Beta-lactam Antibiotics in Intensive Care Unit Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma samples at three consecutive days for measurement of plasma drug concentrations'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-01', 'studyFirstSubmitDate': '2015-04-24', 'studyFirstSubmitQcDate': '2015-05-15', 'lastUpdatePostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of patients below 16mg/L for piperacillin-tazobactam, 2 mg/L for meropenem and 4mg/L for cefotaxim', 'timeFrame': '3 days'}], 'secondaryOutcomes': [{'measure': 'Mortality in relation to initial levels of beta-lactam antibiotics as defined in primary outcome', 'timeFrame': '30 days'}, {'measure': 'The rate of patients below 100% time over MIC in relation to the bacteria causing the infection.', 'timeFrame': '3 days'}, {'measure': 'Kidney function measured as eGFR in relation to initial levels of beta-lactam antibiotics as defined in primary outcome', 'timeFrame': '3 days'}, {'measure': 'SAPS-score in relation to initial levels of beta-lactam antibiotics as defined in primary outcome', 'timeFrame': '3 days'}, {'measure': 'Days in intensive care unit in relation to initial levels of beta-lactam antibiotics as defined in primary outcome', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '24045886', 'type': 'BACKGROUND', 'citation': 'Udy AA, Roberts JA, Lipman J. Clinical implications of antibiotic pharmacokinetic principles in the critically ill. Intensive Care Med. 2013 Dec;39(12):2070-82. doi: 10.1007/s00134-013-3088-4. Epub 2013 Sep 18.'}]}, 'descriptionModule': {'briefSummary': 'In this project, intensive care unit (ICU) patients treated with beta-lactam antibiotics are included with the aim to investigate the potential underdosing in this patient group. Four regional ICU-clinics are recruiting consecutive patients (n=120) and samples are taken before the next dose is administered for three consecutive days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Intensive care unit patients treated with beta-lactam antibiotics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current treatment with beta-lactam antibiotics and admission to the ICU\n\nExclusion Criteria:\n\n* Pregnancy, age below 18 years'}, 'identificationModule': {'nctId': 'NCT02446392', 'acronym': 'TDM-ICU', 'briefTitle': 'The Distribution of Plasma Drug Concentrations of Beta-lactam Antibiotics in Intensive Care Unit Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'The Distribution of Plasma Drug Concentrations of Beta-lactam Antibiotics in Intensive Care Unit Patients', 'orgStudyIdInfo': {'id': 'TDM-ICU'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention.', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '391 85', 'city': 'Jönköping', 'state': 'Jönköping County', 'country': 'Sweden', 'facility': 'Intensive care unit', 'geoPoint': {'lat': 57.78145, 'lon': 14.15618}}, {'zip': '39185', 'city': 'Kalmar', 'state': 'Kalmar County', 'country': 'Sweden', 'facility': 'Intensive Care Unit', 'geoPoint': {'lat': 56.66157, 'lon': 16.36163}}, {'zip': '581 85', 'city': 'Linköping', 'state': 'Linköping', 'country': 'Sweden', 'facility': 'Intensive Care Unit', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'zip': '391 85', 'city': 'Vaxjo', 'state': 'Växjö', 'country': 'Sweden', 'facility': 'Intensive care unit', 'geoPoint': {'lat': 56.87767, 'lon': 14.80906}}], 'overallOfficials': [{'name': 'Thomas Schön, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Linkoeping University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD (Associate professor)', 'investigatorFullName': 'Thomas Schon', 'investigatorAffiliation': 'Linkoeping University'}}}}