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Clinical Trials/NCT03848091
NCT03848091
Completed
Not Applicable

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

Hospices Civils de Lyon1 site in 1 country13 target enrollmentApril 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prosthetic Joint Infection
Sponsor
Hospices Civils de Lyon
Enrollment
13
Locations
1
Primary Endpoint
Rate of Treatment Failure
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2016
End Date
January 1, 2018
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eugénie MABRUT

CRA

Hospices Civils de Lyon

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Rate of Treatment Failure

Time Frame: 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 Outcomes

  • 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)
  • 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)

Study Sites (1)

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