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

Not Applicable

Recruiting

• Conditions: Periprosthetic Joint Infection; Antibiotic Suppression
• Interventions: Drug: 12 months of SAT; Drug: Indefinite SAT; Drug: 6 months of SAT

• Registration Number: NCT05495815
• Lead Sponsor: University of Maryland, Baltimore

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-23
• Last Update Posted: 2024-11-26
• Study Start: 2024-12
• Primary Completion: 2026-01
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 438

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12 months of SAT	12 months of SAT	TJA DAIR, followed by 6 weeks of IV antibiotics then 12 months of oral suppressive antibiotic therapy
Indefinite SAT	Indefinite SAT	TJA DAIR, followed by 6 weeks of IV antibiotics then indefinite oral suppressive antibiotic therapy
6 months of SAT	6 months of SAT	TJA DAIR, followed by 6 weeks of IV antibiotics then 6 months of oral suppressive antibiotic therapy

Primary Outcome Measures

Name	Time	Method
Reoperation for infection recurrence	2 years after patient enrollment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Maryland; 🇺🇸 Baltimore, Maryland, United States