Dosing of Antibiotics During Reimplantation of Infected Knee and Hip Prostheses (DOSOS)

Dosing of Antibiotics (Serum and Periprosthetic Tissues) 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

Study Overview

• Status: Completed
• Conditions: Prosthesis-Related Infections

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU
  • Caen, France, 14033
    • CHU
  • Lille, France, 59037
    • CHRU
  • Rouen, France, 76031
    • CHU
  • Tourcoing, France, 59208
    • Dron Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with hip and knee prostheses infections

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
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	1 day

Collaborators and Investigators

• Sponsor: Tourcoing Hospital
• Investigators: Study Director: Eric M Senneville, MD, PhD, Dron Hospital Tourcoing France; Principal Investigator: Sophie Nguyen, MD, Dron Hospital Tourcoing France

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): October 3, 2017
• Study Completion (Actual): October 3, 2017

Study Registration Dates

• First Submitted: August 5, 2016
• First Submitted That Met QC Criteria: August 5, 2016
• First Posted (Estimate): August 9, 2016

Study Record Updates

• Last Update Posted (Actual): October 11, 2017
• Last Update Submitted That Met QC Criteria: October 10, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Prosthesis-Related Infections; Antibiotic dosing; Reimplantation; Knee-prothesis; Hip-prothesis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Prosthesis-Related Infections
• Other Study ID Numbers: 2013-000889-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO