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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03850860
Enrollment
178
Registered
2019-02-22
Start date
2018-12-01
Completion date
2019-06-01
Last updated
2023-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone and Joint Infection

Keywords

prosthetic joint infection, empirical antibiotherapy, acute kidney injury, vancomycin, cefepim, Piperacillin/tazobactam

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.

Interventions

OTHERempirical antibiotherapy

comparison of the outcome in the 2 groups having had 2 different empirical antibiotherapies

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of Treatment FailureOutcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruptionTreatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin

Secondary

MeasureTime frameDescription
rate of adverse eventsOutcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruptionDescription of adverses events leading to stop the empirical treatment
rate of bacteria responsible for infectionOutcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruptionbacterial epidemiology

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026