The Pharmacokinetics/Pharmacodynamics of High-dose Daptomycin in Patients With Septic Shock
The Pharmacokinetics and Pharmacodynamics of High-dose Daptomycin in Patients With Septic Shock
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 18, 2015
CompletedFirst Posted
Study publicly available on registry
July 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 24, 2015
July 1, 2015
11 months
July 18, 2015
July 22, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Area under the curve(AUC)/Minimum inhibitory concentration(MIC)
6 days
Peak concentration (Cmax)/Minimum inhibitory concentration(MIC)
6 days
Secondary Outcomes (1)
mortality rate
28 days
Study Arms (1)
daptomycin
EXPERIMENTALDaptomycin for injection 10-12mg/kg/day,determination of plasma concentration
Interventions
Drug: Daptomycin for Injection（Cubicin,AstraZeneca） dosage: 10-12mg/kg/day frequency: once a day duration: 14 days
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.
Eligibility Criteria
You may qualify if:
- ≥18 years and ≤75 years
- confirmed or suspected bloodstream and soft tissue infections caused by a grampositive organism
You may not qualify if:
- known hypersensitivity to daptomycin or product excipients
- documented or suspected pneumonia caused by a grampositive organism
- infection with a daptomycin-resistant organism
- presence or history of rhabdomyolysis
- signs or symptoms of myopathy with an elevation of creatine phosphokinase concentrations 6.pregnancy or breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhongda Hospitallead
Study Sites (1)
Zhongda hospital, Southeast University
Nanjing, Jiangsu, 210009, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yingzi - Huang
southeast univerity, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
July 18, 2015
First Posted
July 24, 2015
Study Start
January 1, 2015
Primary Completion
December 1, 2015
Study Completion
June 1, 2016
Last Updated
July 24, 2015
Record last verified: 2015-07