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Dosing of Antibiotics During Reimplantation of Infected Knee and Hip Prostheses

NCT ID: NCT02860767

Last Updated: 2017-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-10-03

Brief Summary

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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

Detailed Description

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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).

Conditions

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Prosthesis-Related Infections

Keywords

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Prosthesis-Related Infections Antibiotic dosing Reimplantation Knee-prothesis Hip-prothesis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tourcoing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric M Senneville, MD, PhD

Role: STUDY_DIRECTOR

Dron Hospital Tourcoing France

Sophie Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

Dron Hospital Tourcoing France

Locations

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CHU

Amiens, , France

Site Status

CHU

Caen, , France

Site Status

CHRU

Lille, , France

Site Status

CHU

Rouen, , France

Site Status

Dron Hospital

Tourcoing, , France

Site Status

Countries

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France

Other Identifiers

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2013-000889-11

Identifier Type: -

Identifier Source: org_study_id