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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Periprosthetic Joint Infection; Antibiotic Suppression
• Intervention / Treatment: Drug: 6 months of SAT; Drug: 12 months of SAT; Drug: Indefinite SAT

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 6 months of SAT; TJA DAIR, followed by 6 weeks of IV antibiotics then 6 months of oral suppressive antibiotic therapy	Drug: 6 months of SAT; 6 months of oral suppressive antibiotic therapy
Active Comparator: 12 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; 12 months of oral suppressive antibiotic therapy
Active Comparator: Indefinite SAT; TJA DAIR, followed by 6 weeks of IV antibiotics then indefinite oral suppressive antibiotic therapy	Drug: Indefinite SAT; Indefinite oral suppressive antibiotic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reoperation for infection recurrence	2 years after patient enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Antibiotic intolerance is any Grade I sign from CTCAE v5.0, while adverse drug reaction is any Grade 2 sign or higher.	During antibiotic administration (up to 2 years after patient enrollment)

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: OrthoCarolina Research Institute, Inc.; University of Arkansas; MedStar Health; NYU School of Medicine; OrthoMichigan; Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: diamine N-acetyltransferase
• Other Study ID Numbers: Maryland

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No