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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03209921
Other study ID # 69HCL17_0464
Secondary ID
Status Completed
Phase N/A
First received July 4, 2017
Last updated July 4, 2017
Start date May 2015
Est. completion date September 2015

Study information

Verified date July 2017
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Outcome

Type Measure Description Time frame Safety issue
Primary Typical daptomycin clearance Mean daptomycin plasma clearance (unit, liters per hour)
Outcome measures performed regularly in those patients throughout therapy, roughly every month.
6 months
Primary Typical daptomycin volume of distribution Mean daptomycin volume of distribution (unit, liters) in the population 6 months
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