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Completed

NCT Number: NCT03850860

Comparison of Two Empirical Antimicrobial Therapies of Prosthetic Joint Infection

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

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Key information

Conditions

Bone and Joint Infection Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon

Lyon, 69004, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

empirical antibiotherapy

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. rate of adverse events

    Time frame: 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

  2. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 22, 2019
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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