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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02508350
• Other study ID #: 2015Dapto
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2015
• Last updated: July 22, 2015
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2015
• Source: Zhongda Hospital
• Contact: Yingzi - Huang, doctor
• Phone: 13951693278
• Email: yz_huang[@]126.com
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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.

Locations

Country	Name	City	State
China	Zhongda hospital, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve(AUC)/Minimum inhibitory concentration(MIC)		6 days	No
Primary	Peak concentration (Cmax)/Minimum inhibitory concentration(MIC)		6 days	No
Secondary	mortality rate		28 days	No