Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-04-19 @ 8:13 PM
Study NCT ID:
NCT03004066
Status:
COMPLETED
Last Update Posted:
2019-04-19
First Post:
2016-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daptomycin Concentration in Drainage Fluid and Blood Samples of ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017576', 'term': 'Daptomycin'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-18', 'studyFirstSubmitDate': '2016-11-16', 'studyFirstSubmitQcDate': '2016-12-21', 'lastUpdatePostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'levels of Daptomycin in drainage fluid', 'timeFrame': '4 days', 'description': 'Pharmacokinetics of Daptomycin in intensive care patients with wound drainage after surgery (LVAD implantation)'}, {'measure': 'levels of Daptomycin in blood samples', 'timeFrame': '4 days', 'description': 'Pharmacokinetics of Daptomycin in intensive care patients after surgery (LVAD implantation)'}], 'secondaryOutcomes': [{'measure': 'infections', 'timeFrame': '14 days', 'description': 'incidence of gram-positive infections'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Assist Device']}, 'descriptionModule': {'briefSummary': '10 patients with chronic heart failure receiving daptomycin therapy after implantation of a left ventricular heart assist system. Measurement of daptomycin levels in drainage fluids (mediastinal and pleural drainage systems) and in blood samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients after heart assist device implantation with wound drainage receiving daptomycin therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written consent\n* heart assist device implantation\n* wound drainage\n* daptomycin therapy\n\nExclusion Criteria:\n\n* pregnancy\n* no written consent possible\n* absence of wound drainage\n* allergy to study medication\n* acute rhabdomyolysis'}, 'identificationModule': {'nctId': 'NCT03004066', 'briefTitle': 'Daptomycin Concentration in Drainage Fluid and Blood Samples of ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Daptomycin Concentration in Drainage Fluid and Blood Samples of ICU Patients', 'orgStudyIdInfo': {'id': 'Dapto'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Daptomycin', 'type': 'DRUG', 'description': 'standard care'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'University Hospital Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Stefanie Prohaska, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Tuebingen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}