Randomized Clinical Trial Determining Proper Duration of Suppressive Antibiotic Therapy After Total Joint Arthroplasty Debridement, Antibiotics, and Implant Retention (ProperSAT)

NCT05495815 NA WITHDRAWN

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.

Details

Lead sponsor	University of Maryland, Baltimore
Phase	NA
Status	WITHDRAWN
Start date	2024-12
Completion	2026-06

Conditions

• Periprosthetic Joint Infection
• Antibiotic Suppression

Interventions

• 6 months of SAT
• 12 months of SAT
• Indefinite SAT

Primary outcomes

• Reoperation for infection recurrence — 2 years after patient enrollment

Countries

United States