COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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. Identifier: NCT03209921
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : July 6, 2017
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

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

Inclusion Criteria:

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

Exclusion Criteria:


Layout table for additonal information
Responsible Party: Hospices Civils de Lyon 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

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Arthritis, Infectious
Joint Diseases
Musculoskeletal Diseases