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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

Tracking Information
First Submitted Date February 19, 2019
First Posted Date February 20, 2019
Last Update Posted Date February 20, 2019
Actual Study Start Date April 1, 2016
Actual Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 19, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 19, 2019)
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prosthesis Infection and One-step Exchange: Pretreatment by Targeted Antibiotic Therapy in At-risk Patients
Official Title Prosthesis Infection and One-step Exchange: Pretreatment by Targeted Antibiotic Therapy in
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Prosthetic Joint Infection
  • Antibiotic Resistant Infection
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,...)
Study Groups/Cohorts Antibiotic pretreatment
patients having had an antibiotic pretreatment before a one-step exchange arthroplasty
Intervention: Other: Antibiotic pretreatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 19, 2019)
13
Original Actual Enrollment Same as current
Actual Study Completion Date January 1, 2018
Actual Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
Sex/Gender Not Provided
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03848091
Other Study ID Numbers 18-030
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Eugénie MABRUT, Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators
Principal Investigator: Tristan Ferry, Md,PhD HCL
PRS Account Hospices Civils de Lyon
Verification Date February 2019