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

Bone and Joint Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209921
• Other study ID #: 69HCL17_0464
• 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
• 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:

Related Conditions & MeSH terms

• Arthritis, Infectious
• Bone and Joint Infection
• Communicable Diseases
• Infection
• Patient Treated by Daptomycin

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