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

February 27, 2024 updated by: Eugénie MABRUT, Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69004
        • Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Antibiotic pretreatment
patients having had an antibiotic pretreatment before a one-step exchange arthroplasty
Other: Antibiotic pretreatment
a strategy with antibiotic pretreatment before one-step exchange arthroplasty in patients who bacteria responsible for the infection has been indentified (puncture, blood cultures,...)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of use of this strategy
Time Frame: 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
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
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
bacterial epidemiology
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Tristan Ferry, Md,PhD, HCL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

February 19, 2019

First Posted (Actual)

February 20, 2019

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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