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Clinical Trials/NCT03209921
NCT03209921
Completed
Not Applicable

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

Hospices Civils de Lyon0 sites23 target enrollmentMay 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bone and Joint Infection
Sponsor
Hospices Civils de Lyon
Enrollment
23
Primary Endpoint
Typical daptomycin clearance
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
September 2015
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Typical daptomycin clearance

Time Frame: 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

Time Frame: 6 months

Mean daptomycin volume of distribution (unit, liters) in the population

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