Multiple studies have demonstrated oral suppressive antibiotic therapy (SAT), after intravenous antibiotics, maximizes reoperation-free survival of total joint arthroplasty (TJA) debridement, antibiotics, and implant retention (DAIR) for acute periprosthetic joint infection (PJI). However, little is known regarding sequelae of SAT after DAIR for PJI. Prior studies have small or heterogeneous patient cohorts, variable antibiotic regimens, arrive at disparate conclusions, and do not establish antibiotic resistance risk. The investigators propose a prospective randomized controlled multicenter study to expand on findings in a retrospective, multi-center pilot study. Study aims are to evaluate SAT after DAIR of acutely infected primary TJA regarding: 1) adverse drug reactions/intolerance; 2) reoperation for infection; and 3) antibiotic resistance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
6 months of oral suppressive antibiotic therapy
12 months of oral suppressive antibiotic therapy
Indefinite oral suppressive antibiotic therapy
University of Maryland
Baltimore, Maryland, United States
Reoperation for infection recurrence
Time frame: 2 years after patient enrollment
Antibiotic resistance, evidenced by change in antimicrobial sensitivity profile, developed by infecting organism after suppressive antibiotic therapy causing infection recurrence
Time frame: At time of reoperation (within 2 years of patient enrollment)
Adverse drug reaction or intolerance, defined as any symptom or laboratory value derangement requiring a change in, or discontinuation of, antimicrobial therapy
Antibiotic intolerance is any Grade I sign from CTCAE v5.0, while adverse drug reaction is any Grade 2 sign or higher.
Time frame: During antibiotic administration (up to 2 years after patient enrollment)
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