NCT05495815

Proper Duration of Suppressive Antibiotic Therapy After Debridement, Antibiotics, and Implant Retention

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Periprosthetic Joint Infection
• Antibiotic Suppression

Interventions

Type	Name	Description
DRUG	6 months of SAT	6 months of oral suppressive antibiotic therapy
DRUG	12 months of SAT	12 months of oral suppressive antibiotic therapy
DRUG	Indefinite SAT	Indefinite oral suppressive antibiotic therapy

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-02-01
• Completion: 2026-06-01
• First posted: 2022-08-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: United States