Comparison of Two Empirical Antimicrobial Therapies of Prosthetic Joint Infection

Study Overview
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Brief Summary
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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

Detailed Description
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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. The empirical antimicrobial therapy of PJI is associated with an important rate of adverse, linked with the use of the vancomycin and the piperacillin-tazobactam combination. Some studies suggest to use vancomycin-cefepime, which remains to be evaluated in PJI.

Official Title
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Comparison of the Tolerance of Vancomycin in Combination With Piperacillin/Tazobactam or Cefepim as Empirical Antimicrobial Therapy of Prosthetic Joint Infection

Conditions
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Bone and Joint Infection

Intervention / Treatment
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* Other: empirical antibiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion 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 Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| empirical antibotherapy currently used<br>patients having had a vancomycin and piperacillin-tazobactam combination as empirical antibiotherapy | Other: empirical antibiotherapy<br>* comparison of the outcome in the 2 groups having had 2 different empirical antibiotherapies<br>|
| another empirical antibotherapy<br>patients having had a vancomycin and cefepime combination as empirical antibiotherapy | Other: empirical antibiotherapy<br>* comparison of the outcome in the 2 groups having had 2 different empirical antibiotherapies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of adverse events | Description of adverses events leading to stop the empirical treatment | 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 | bacterial epidemiology | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Piperacillin/tazobactam, prosthetic joint infection, empirical antibiotherapy, acute kidney injury, vancomycin, cefepim