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

NCT03848091 | Completed

• 1 other identifier: 18-030
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Prosthetic Joint Infection; Antibiotic Resistant Infection

Keywords

bone and joint infection; Antibiotic pretreatment

Outcome Measures

Primary Outcomes (1)

• Rate of Treatment Failure

  Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin

  Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption

Secondary Outcomes (2)

• 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

• 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

Study Arms (1)

Antibiotic pretreatment

patients having had an antibiotic pretreatment before a one-step exchange arthroplasty

Other: Antibiotic pretreatment

Interventions

Antibiotic pretreatment OTHER

a strategy with antibiotic pretreatment before one-step exchange arthroplasty in patients who bacteria responsible for the infection has been indentified (puncture, blood cultures,...)

Antibiotic pretreatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients having had a antibiotic pretreatment targeted before a one step exchange arthroplasty managed at the Croix-Rousse Hospital

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

Location

Study Officials

• Tristan Ferry, Md,PhD

  HCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CRA

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 20, 2019
• Study Start: April 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

FR (1)