The Pharmacokinetics and Pharmacodynamics of High-dose Daptomycin in Patients With Septic Shock
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Area under the curve(AUC)/Minimum inhibitory concentration(MIC)
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥18 years and ≤75 years
- •confirmed or suspected bloodstream and soft tissue infections caused by a grampositive organism
Exclusion Criteria
- •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
Arms & Interventions
daptomycin
Daptomycin for injection 10-12mg/kg/day,determination of plasma concentration
Intervention: Daptomycin (Drug)
daptomycin
Daptomycin for injection 10-12mg/kg/day,determination of plasma concentration
Intervention: determination of plasma concentration (Other)
Outcomes
Primary Outcomes
Area under the curve(AUC)/Minimum inhibitory concentration(MIC)
Time Frame: 6 days
Peak concentration (Cmax)/Minimum inhibitory concentration(MIC)
Time Frame: 6 days
Secondary Outcomes
- mortality rate(28 days)
Investigators
Yingzi Huang
Chief Physician
Zhongda Hospital