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OpenTrials
Completed

NCT Number: NCT03209921

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 6, 2017
Registry last updated
Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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