Comparison of Two Empirical Antimicrobial Therapies of Prosthetic Joint Infection

Bone and Joint Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03850860
• Other study ID #: 18-326
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: September 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: June 1, 2019
• Est. primary completion date: March 1, 2019
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Infectious
• Bone and Joint Infection
• Communicable Diseases
• Infections

Intervention

Other:
• empirical antibiotherapy
comparison of the outcome in the 2 groups having had 2 different empirical antibiotherapies

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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