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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209921
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Bone and Joint Infection Patient Treated by Daptomycin

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Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pharmacokinetic Variability of Daptomycin During Prolonged Therapy for Bone and Joint Infections
Actual Study Start Date : May 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Daptomycin




Primary Outcome Measures :
  1. 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.


  2. Typical daptomycin volume of distribution [ Time Frame: 6 months ]
    Mean daptomycin volume of distribution (unit, liters) in the population



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with daptomycin for BJI in Lyon Center in 2012 and 2013
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03209921    
Other Study ID Numbers: 69HCL17_0464
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Bone and Joint Infection
Daptomycin
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases