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Trial record 33 of 47 for:    "Prosthetic Joint Infection"

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

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ClinicalTrials.gov Identifier: NCT03848091
Recruitment Status : Completed
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Eugénie MABRUT, Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment
Prosthetic Joint Infection Antibiotic Resistant Infection Other: Antibiotic pretreatment

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Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prosthesis Infection and One-step Exchange: Pretreatment by Targeted Antibiotic Therapy in
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine


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,...)




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848091


Locations
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France
Hospices Civils de Lyon
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Tristan Ferry, Md,PhD HCL

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Responsible Party: Eugénie MABRUT, CRA, Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03848091     History of Changes
Other Study ID Numbers: 18-030
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eugénie MABRUT, Hospices Civils de Lyon:
bone and joint infection
Antibiotic pretreatment

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents