Skip to main content
Clinical Trials/ACTRN12617000127303
ACTRN12617000127303
Completed
Phase 4

Pilot trial evaluating the efficacy of different antibiotic treatments for the treatment of prosthetic joint infection in adults who have undergone joint replacement surgery.

John Hunter Hospital0 sites60 target enrollmentJanuary 24, 2017

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Prosthetic joint infection
Sponsor
John Hunter Hospital
Enrollment
60
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 24, 2017
End Date
December 15, 2020
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\) Aged \>\=18 years
  • 2\) Prosthetic joint infection of the hip or knee (according to IDSA diagnostic criteria)
  • 3\) Acute infection (either a. Diagnosis \<4 weeks from date of implantation of prosthesis OR b. Suspected acute haematogenous infection with \<3 weeks from symptom onset to diagnosis)
  • 4\) Meet IDSA criteria for DAIR (stable implant, no sinus, absence of septic shock).
  • 5\) One or more identified causative organisms (can be Gram positive, Gram negative or mixed)
  • 6\) Adequate debridement has been performed or is planned (this means an open as opposed to arthroscopic debridement and exchange of modular components)
  • 7\) Initial diagnosis is \<21 days prior to randomisation.

Exclusion Criteria

  • 1\) Additional diagnosis requiring \>2 weeks of IV antibiotics in the opinion of the site PI (e.g. Staphylococcus aureus bacteraemia).
  • 2\) Patient not treated with curative intent.
  • 3\) Patient unlikely to survive for \> 12 months (in the opinion of the site PI).
  • 4\) Gram positive rifampicin resistant causative organism.
  • 5\) Gram negative ciprofloxacin resistant causative organism.
  • 6\) At least one causative organism is Proprionibacterium spp., Gram negative anaerobes, Fungi, Mycobacteria.

Outcomes

Primary Outcomes

Not specified

Similar Trials