Prosthesis Infection and One-step Exchange: Pretreatment by Targeted Antibiotic Therapy in At-risk Patients

Completed

• Conditions: Prosthetic Joint Infection; Antibiotic Resistant Infection

• Registration Number: NCT03848091
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

One-step exchange arthroplasty is more and more used in the treatment of chronic infections, especially in patients at risk anesthetic.

This strategy is not recommended in patients infected with multidrug-resistant organisms or difficult to treat because of a risk of bacterial persistence on the new implant.

Antibiotic pretreatment by a narrow-spectrum molecule and for which resistance acquisition is difficult might be of interest to try to reduce the inoculum and avoid contamination of the new implant.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-01
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-01
• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• patients having had a antibiotic pretreatment targeted before a one step exchange arthroplasty

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Treatment Failure	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption	Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin

Secondary Outcome Measures

Name	Time	Method
rate of bacteria responsible for infection	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption	bacterial epidemiology
rate of use of this strategy	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption	descriptions of patients managed with this strategy

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France