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NCT03848091 Clinical Trial

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

Antibiotic Resistant Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03848091
Other study ID # 18-030
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2016
Est. completion date January 1, 2018

Study information
Verified date February 2024
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date January 1, 2018
Est. primary completion date January 1, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - patients having had a antibiotic pretreatment targeted before a one step exchange arthroplasty Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

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,...)

Locations
Country Name City State
France Hospices Civils de Lyon Lyon

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 rate of use of this strategy 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
Secondary rate of bacteria responsible for infection bacterial epidemiology Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
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