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

University of Maryland Baltimore (UMB)

Status: Enrolling

Conditions: Periprosthetic Joint Infection; Antibiotic Suppression

Treatments: Drug: Indefinite SAT; Drug: 6 months of SAT; Drug: 12 months of SAT

Study type: Interventional

Funder types: Other

Identifiers

NCT05495815

Maryland

Details and patient eligibility

About

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.

Enrollment: 438 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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438 participants in 3 patient groups

6 months of SAT

Active Comparator group

Description:

TJA DAIR, followed by 6 weeks of IV antibiotics then 6 months of oral suppressive antibiotic therapy

Treatment:

Drug: 6 months of SAT

12 months of SAT

Active Comparator group

Description:

TJA DAIR, followed by 6 weeks of IV antibiotics then 12 months of oral suppressive antibiotic therapy

Treatment:

Drug: 12 months of SAT

Indefinite SAT

Active Comparator group

Description:

TJA DAIR, followed by 6 weeks of IV antibiotics then indefinite oral suppressive antibiotic therapy

Treatment:

Drug: Indefinite SAT