Dosing of Antibiotics During Reimplantation of Infected Knee and Hip Prostheses

Prosthesis-Related Infections Clinical Trial

— DOSOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860767
• Other study ID #: 2013-000889-11
• Status: Completed
• Phase: N/A
• First received: August 5, 2016
• Last updated: October 10, 2017
• Start date: August 2016
• Est. completion date: October 3, 2017

Study information

• Verified date: August 2016
• Source: Tourcoing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 3, 2017
• Est. primary completion date: October 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prosthesis-Related Infections

Locations

Country	Name	City	State
France	CHU	Amiens
France	CHU	Caen
France	CHRU	Lille
France	CHU	Rouen
France	Dron Hospital	Tourcoing

Sponsors (1)

Lead Sponsor	Collaborator
Tourcoing Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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