Comparison of Two Empirical Antimicrobial Therapies of Prosthetic Joint Infection

Completed

• Conditions: Bone and Joint Infection
• Interventions: Other: empirical antibiotherapy

• Registration Number: NCT03850860
• Lead Sponsor: Hospices Civils de Lyon

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

Detailed Description

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.

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-22
• Primary Completion: 2019-03-01
• Study Completion: 2019-06-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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

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Exclusion Criteria

• none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
empirical antibotherapy currently used	empirical antibiotherapy	patients having had a vancomycin and piperacillin-tazobactam combination as empirical antibiotherapy
another empirical antibotherapy	empirical antibiotherapy	patients having had a vancomycin and cefepime combination as empirical antibiotherapy

Primary Outcome Measures

Name	Time	Method
Rate of Treatment Failure	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

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

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France