Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT02508350
Status:
UNKNOWN
Last Update Posted:
2015-07-24
First Post:
2015-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Pharmacokinetics/Pharmacodynamics of High-dose Daptomycin in Patients With Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'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'}, {'id': 'D012769', 'term': 'Shock'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-22', 'studyFirstSubmitDate': '2015-07-18', 'studyFirstSubmitQcDate': '2015-07-22', 'lastUpdatePostDateStruct': {'date': '2015-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve(AUC)/Minimum inhibitory concentration(MIC)', 'timeFrame': '6 days'}, {'measure': 'Peak concentration (Cmax)/Minimum inhibitory concentration(MIC)', 'timeFrame': '6 days'}], 'secondaryOutcomes': [{'measure': 'mortality rate', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Septic Shock']}, 'descriptionModule': {'briefSummary': 'The first objective of this study was to characterize the pharmacokinetics and pharmacodynamics of daptomycin with a daily dose of 12mg/kg in septic shock patient; the second objective is to identify the optimal dosing scheme for daptomycin among patients with septic shock and to enhance therapeutic outcomes.', 'detailedDescription': 'Daptomycin is a novel lipopeptide exhibiting concentration-dependent bactericidal activity against multidrug-resistant Gram-positive pathogens, including Methicillin-resistant Staphylococcus aureus (MRSA). In recent years, daptomycin plays an important role in the treatment of septic shock. The pharmacokinetics of daptomycin is significant changed in patients with septic shock, it is proved that the recent dosage regiment comes with a low blood drug concentration and unsatisfactory outcome. Although the high-dose daptomycin shows safety and effectiveness in the treatment of critically ill patient, but still the pharmacokinetics and pharmacodynamics data is scant. So the purposes of this study is to characterize the pharmacokinetics and pharmacodynamics of daptomycin with a daily dose of 12mg/kg in septic shock patient; the second objective is to identify the optimal dosing scheme for daptomycin among patients with septic shock and to enhance therapeutic outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years and ≤75 years\n* confirmed or suspected bloodstream and soft tissue infections caused by a grampositive organism\n\nExclusion Criteria:\n\n* known hypersensitivity to daptomycin or product excipients\n* documented or suspected pneumonia caused by a grampositive organism\n* infection with a daptomycin-resistant organism\n* presence or history of rhabdomyolysis\n* signs or symptoms of myopathy with an elevation of creatine phosphokinase concentrations 6.pregnancy or breast-feeding'}, 'identificationModule': {'nctId': 'NCT02508350', 'briefTitle': 'The Pharmacokinetics/Pharmacodynamics of High-dose Daptomycin in Patients With Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Zhongda Hospital'}, 'officialTitle': 'The Pharmacokinetics and Pharmacodynamics of High-dose Daptomycin in Patients With Septic Shock', 'orgStudyIdInfo': {'id': '2015Dapto'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'daptomycin', 'description': 'Daptomycin for injection 10-12mg/kg/day,determination of plasma concentration', 'interventionNames': ['Drug: Daptomycin', 'Other: determination of plasma concentration']}], 'interventions': [{'name': 'Daptomycin', 'type': 'DRUG', 'otherNames': ['Cubicin'], 'description': 'Drug: Daptomycin for Injection（Cubicin,AstraZeneca） dosage: 10-12mg/kg/day frequency: once a day duration: 14 days', 'armGroupLabels': ['daptomycin']}, {'name': 'determination of plasma concentration', 'type': 'OTHER', 'description': 'A maximum of 12 blood samples (1.5mL) were collected in Ethylenediaminetetraacetic acid disodium salt (EDTA-Na2) tubes over a 6-dose administration sequence.Sampling was done prior to the administration of the first dose, at 30 minutes (end of infusion),and at 4,12,and 24 hours after the initial dose.Additional blood samples were collected at the end of infusion (peak) and prior to the subsequent dose (trough) for doses 2-5.After the sixth dose the blood samples were collected prior to the administration and at 4,and 24 hours after the end of infusion.', 'armGroupLabels': ['daptomycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Nan Guo', 'role': 'CONTACT', 'email': 'guonan8910@163.com', 'phone': '15850681416'}], 'facility': 'Zhongda hospital, Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Yingzi - Huang, doctor', 'role': 'CONTACT', 'email': 'yz_huang@126.com', 'phone': '13951693278'}, {'name': 'Hua - Shao, doctor', 'role': 'CONTACT', 'email': 'gycsh@163.com', 'phone': '13851725783'}], 'overallOfficials': [{'name': 'Yingzi - Huang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'southeast univerity, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongda Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Yingzi Huang', 'investigatorAffiliation': 'Zhongda Hospital'}}}}