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

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.

Study Overview

• Status: Unknown
• Conditions: Septic Shock
• Intervention / Treatment: Drug: Daptomycin; Other: determination of plasma concentration

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 Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yingzi - Huang, doctor; Phone Number: 13951693278; Email: yz_huang@126.com
• Study Contact Backup: Name: Hua - Shao, doctor; Phone Number: 13851725783; Email: gycsh@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zhongda Hospital, Southeast University
      • Contact: Nan Guo; Phone Number: 15850681416; Email: guonan8910@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: daptomycin; Daptomycin for injection 10-12mg/kg/day,determination of plasma concentration

Drug: Daptomycin; Drug: Daptomycin for Injection（Cubicin,AstraZeneca） dosage: 10-12mg/kg/day frequency: once a day duration: 14 days; Other Names: Cubicin; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the curve(AUC)/Minimum inhibitory concentration(MIC)	6 days
Peak concentration (Cmax)/Minimum inhibitory concentration(MIC)	6 days

Secondary Outcome Measures

Outcome Measure	Time Frame
mortality rate	28 days

Collaborators and Investigators

• Sponsor: Zhongda Hospital
• Investigators: Study Director: Yingzi - Huang, southeast univerity, China

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: July 18, 2015
• First Submitted That Met QC Criteria: July 22, 2015
• First Posted (Estimate): July 24, 2015

Study Record Updates

• Last Update Posted (Estimate): July 24, 2015
• Last Update Submitted That Met QC Criteria: July 22, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock; Anti-Infective Agents; Anti-Bacterial Agents; Daptomycin
• Other Study ID Numbers: 2015Dapto