The Pharmacokinetics/Pharmacodynamics of High-dose Daptomycin in Patients With Septic Shock

Southeast University

Status: Unknown

Conditions: Septic Shock

Treatments: Drug: Daptomycin; Other: determination of plasma concentration

Study type: Interventional

Funder types: Other

Identifiers

NCT02508350

2015Dapto

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

12 participants in 1 patient group

daptomycin

Experimental group

Description:

Daptomycin for injection 10-12mg/kg/day,determination of plasma concentration

Treatment:

Other: determination of plasma concentration

Drug: Daptomycin