Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-29 @ 5:02 PM
Study NCT ID:
NCT01212432
Status:
UNKNOWN
Last Update Posted:
2010-10-18
First Post:
2010-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Finding Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, '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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-10-15', 'studyFirstSubmitDate': '2010-09-29', 'studyFirstSubmitQcDate': '2010-09-29', 'lastUpdatePostDateStruct': {'date': '2010-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': '2011'}]}, 'conditionsModule': {'keywords': ['Gram positive infection and CRRT'], 'conditions': ['Gram-Positive Bacterial Infections']}, 'descriptionModule': {'briefSummary': 'Daptomycin kinetics in CRRT\n\n* Trial with medicinal product'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* male or female of 18 years or older\n* females: negative pregnancy test\n* Hospitalisation in the medical ICU\n* High suspicion or evidence of Gram-positive infections requiring antibiotic therapy\n* Subjects receiving standard antibiotic treatment for Gram-positive infection\n* Evidence of renal failure\n* Clinical necessity for continuous renal replacement therapy\n* Written informed consent signed by the patient or a next of kin and an independent physician in case the patient is not able to sign.\n\nExclusion criteria:\n\n* Skeletal muscle disorders or CPK levels of \\> 2 x ULN\n* History of hypersensitivity to the drug\n* Participation in another study\n* Subjects with a history of muscle disease\n* Patients with severe liver function impairment (Child\n* Life expectancy of less than 5 days'}, 'identificationModule': {'nctId': 'NCT01212432', 'briefTitle': 'Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Finding Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'orgStudyIdInfo': {'id': 'DAPTO_CH08'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Daptomycin', 'type': 'DRUG', 'description': 'Daptomycin kinetics in CRRT'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': '01 Studienregister MasterAdmins', 'role': 'CONTACT', 'phone': '+41 (0)44 255 11 11'}], 'overallOfficials': [{'name': '01 Studienregister MasterAdmins', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UniversitaetsSpital Zuerich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Maggiorini Marco, Prof. Dr. med.', 'oldOrganization': 'University Hospital Zurich, Intensivmedizin'}}}}