Status:
UNKNOWN
Or v IV Antibiotics for Infection
Lead Sponsor:
Rothman Institute Orthopaedics
Conditions:
Joint Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Management of periprosthetic joint infection (PJI) commonly includes 6 weeks of intravenous (IV) antibiotics after surgical treatment. However, there is little evidence to suggest that oral (PO) thera...
Eligibility Criteria
Inclusion
- aged ≥ 18 years
- willing and able to give informed consent
- primary THA or TKA diagnosed with PJI based on International Consensus Meeting criteria
- A sinus communicating with the prosthesis OR
- Two positive cultures obtained from the prosthesis OR
- 3 of 5 criteria:
- Elevated ESR (\>30mm/hr) and CRP (\>10mg/L)
- Elevated synovial leukocyte count (\>3000 cells/µL) or change of ++ on leukocyte esterase strip
- Elevated synovial neutrophil percentage (\>80%)
- One positive culture
- Positive histological analysis of periprosthetic tissue (\>5 neutrophils per high power field in 5 high power fields x400)
- PJI treated by debridement and implant retention, or excision of the prosthetic joint (with or without planned reimplantation)
- received ≤ 7 days of IV therapy after an appropriate surgical intervention
Exclusion
- Previously treated for native septic arthritis or PJI in the same joint
- S. aureus bacteremia on presentation or within the previous month
- clinical, histological or microbiological evidence of mycobacterial, fungal or parasitic etiology of the infection
- any other concomitant infection that, in the opinion of the clinician responsible for the patient, requires a prolonged course of IV antibiotic therapy (e.g. bacterial endocarditis, mediastinal infection, central nervous system infection)
- septic shock or systemic features that, in the opinion of the clinician responsible for the patient, requires a course of IV antibiotic therapy (the patient could be re-evaluated if these features resolved)
- an infection for which there are no suitable antibiotic choices to permit randomization between the two arms of the trial (e.g. when organisms are only sensitive to IV antibiotics or PO antibiotics)
- unlikely to comply with trial requirements following randomization in the opinion of the investigator
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 25 2023
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT04723940
Start Date
January 25 2021
End Date
January 25 2023
Last Update
January 26 2021
Active Locations (1)
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1
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107