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Completed

NCT Number: NCT02860767

Dosing of Antibiotics During Reimplantation of Infected Knee and Hip Prostheses

The purpose of the study is to evaluate the concentrations of antibiotics used as empirical treatment in serum and periprosthetic tissues during reimplantation of infected hip and knee prostheses

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU, Amiens, France

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About this study

The purpose of the study is to evaluate the concentrations of antibiotics (daptomycin, vancomycin, cefotaxime, ceftriaxone, cefepime) in serum and periprosthetic tissues(bone and synovial joint) used as empirical treatment during reimplantation of infected hip and knee prostheses (1-stage or 2-stage management).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (aged of 18 years or more) who undergo reimplantation surgery for infected hip or knee prosthesis (performed in 1 or 2-stage(s)), and for whom referral physicians plans to use an empirical antibiotic therapy including cefotaxime, ceftriaxone, cefepime, daptomycin, or vancomycin.

Exclusion criteria

  • Patients with multiple prosthetic joint infections, or with curative antibiotic therapy ongoing within two weeks or less prior to surgery, or for whom an antibiotic prophylaxis is decided by referral for the reimplantation surgery, or for whom an antibiotic-loaded cement containing the same antibiotic chosen for empirical therapy after reimplantation was used in case of 2-stage exchange

Treatment and study plan

Primary outcomes

  1. Primary outcome measure was the evaluation of concentrations in serum and periprosthetic tissues of antibiotic agents used as empirical therapy during reimplantation of the infected prosthesis

    Time frame: 1 day

Secondary outcomes

  1. Secondary outcome will analyze the ratio of antibiotic concentration in serum and prosthetic tissues to minimum inhibitory concentration of the concerned antibiotic for the pathogen(s) identified in intraoperative samples

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Tourcoing Hospital

Other

Registry information

Official study title

Dosing of Antibiotics (Serum and Periprosthetic Tissues) During Reimplantation of Infected Knee and Hip Prostheses

Acronym: DOSOS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 9, 2016
Registry last updated
Oct 11, 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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