An interventional study of 6 months of SAT and 12 months of SAT in Periprosthetic Joint Infection and Antibiotic Suppression, sponsored by University of Maryland, Baltimore. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Treatment
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.
University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
TJA DAIR, followed by 6 weeks of IV antibiotics then 6 months of oral suppressive antibiotic therapy
Drug: 6 months of SAT
TJA DAIR, followed by 6 weeks of IV antibiotics then 12 months of oral suppressive antibiotic therapy
Drug: 12 months of SAT
TJA DAIR, followed by 6 weeks of IV antibiotics then indefinite oral suppressive antibiotic therapy
Drug: Indefinite SAT
6 months of oral suppressive antibiotic therapy
12 months of oral suppressive antibiotic therapy
Indefinite oral suppressive antibiotic therapy
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)
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore