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.
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.
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
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