Comparison of Two Empirical Antimicrobial Therapies of Prosthetic Joint Infection
Comparison of the Tolerance of Vancomycin in Combination With Piperacillin/Tazobactam or Cefepim as Empirical Antimicrobial Therapy of Prosthetic Joint Infection
1 other identifier
observational
178
1 country
1
Brief Summary
The empirical use of vancomycin in combination with a broad-spectrum beta-lactam is currently recommended after the initial surgery of prosthetic joint infection (PJI). However, the tolerability of such high-dose intravenous regimens is poorly known. T
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 20, 2019
CompletedFirst Posted
Study publicly available on registry
February 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedSeptember 22, 2023
September 1, 2023
3 months
February 20, 2019
September 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
rate of adverse events
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
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Study Arms (2)
empirical antibotherapy currently used
patients having had a vancomycin and piperacillin-tazobactam combination as empirical antibiotherapy
another empirical antibotherapy
patients having had a vancomycin and cefepime combination as empirical antibiotherapy
Interventions
comparison of the outcome in the 2 groups having had 2 different empirical antibiotherapies
Eligibility Criteria
patients having had a prosthetic joint infection and having had a postoperative empirical antibiotherapy with combination of vancomycine and piperacillin-tazobactam or vancomycine and cefepime manage at the croix rousse hospital
You may qualify if:
- patients having had a prosthetic joint infection and having had a postoperative empirical antibiotherapy with combination of vancomycine and piperacillin-tazobactam or vancomycine and cefepime
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospices Civils de Lyon
Lyon, 69004, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Florent Valour, Md,PhD
HCL
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinical research assistant
Study Record Dates
First Submitted
February 20, 2019
First Posted
February 22, 2019
Study Start
December 1, 2018
Primary Completion
March 1, 2019
Study Completion
June 1, 2019
Last Updated
September 22, 2023
Record last verified: 2023-09