Pharmacokinetic Variability of Daptomycin During Prolonged Therapy for Bone and Joint Infections

Completed

• Conditions: Bone and Joint Infection; Patient Treated by Daptomycin

• Registration Number: NCT03209921
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Daptomycin is a cyclic lipopeptide that has been proposed as an alternative therapeutic option in patients with prosthetic joint infection caused by Staphylococcus or Enterococcus species in the latest Infectious Diseases Society of America (IDSA) guidelines.

The population pharmacokinetics (PK) of daptomycin have been described in various groups of patients in previous publications. However, little information exists on the PK of daptomycin in patients with bone and joint infections (BJI). Also, previous population studies did not investigate daptomycin PK over prolonged therapy, and, to our knowledge, no study has reported the intraindividual PK variability of this drug.

The aim of this study is to describe the inter- and intraindividual PK variability of this drug.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2017-07
• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-04
• Last Update Submitted: 2017-07-04
• Study First Posted: 2017-07-06
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• patients treated with daptomycin for BJI in Lyon Center in 2012 and 2013

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Typical daptomycin clearance	6 months	Mean daptomycin plasma clearance (unit, liters per hour); Outcome measures performed regularly in those patients throughout therapy, roughly every month.
Typical daptomycin volume of distribution	6 months	Mean daptomycin volume of distribution (unit, liters) in the population