NCT02508350

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Zhongda Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Septic Shock

Interventions

Type	Name	Description
DRUG	Daptomycin	Drug: Daptomycin for Injection（Cubicin,AstraZeneca） dosage: 10-12mg/kg/day frequency: once a day duration: 14 days
OTHER	determination of plasma concentration	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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-12-01
• Completion: 2016-06-01
• First posted: 2015-07-24
• Last updated: 2015-07-24

Locations

1 site across 1 country: China