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OpenTrials
Completed

NCT Number: NCT03848091

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

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.

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Key information

Conditions

Prosthetic Joint Infection Antibiotic Resistant Infection

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon

Lyon, 69004, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

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,...)

Primary outcomes

  1. 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

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 20, 2019
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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