Antibiotic Suppression, Periprosthetic Joint Infection
Conditions
Brief summary
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.
Interventions
DRUG6 months of SAT
6 months of oral suppressive antibiotic therapy
DRUG12 months of SAT
12 months of oral suppressive antibiotic therapy
DRUGIndefinite SAT
Indefinite oral suppressive antibiotic therapy
Sponsors
University of Maryland, Baltimore
OrthoCarolina Research Institute, Inc.
University of Arkansas
OrthoMichigan
NYU School of Medicine
Sinai Hospital
MedStar Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* over 18 years-old * underwent DAIR with modular component exchange for acute TJA PJI, as defined by Musculoskeletal Infection Society Criteria, with symptom duration less than 4 weeks * on postoperative oral SAT for at least 3 months
Exclusion criteria
* underwent aseptic revision surgery * had one-stage, 1.5-stage, or two-stage revision surgery * did not have postoperative SAT * did not have follow-up that allowed for evaluation of SAT sequelae
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reoperation for infection recurrence | 2 years after patient enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibiotic resistance, evidenced by change in antimicrobial sensitivity profile, developed by infecting organism after suppressive antibiotic therapy causing infection recurrence | 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 | During antibiotic administration (up to 2 years after patient enrollment) | Antibiotic intolerance is any Grade I sign from CTCAE v5.0, while adverse drug reaction is any Grade 2 sign or higher. |
Countries
United States
Outcome results
None listed