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

Periprosthetic Joint Infection Clinical Trial

— ProperSAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05495815
• Other study ID #: Maryland
• Status: Recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 438
• Est. completion date: June 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periprosthetic Joint Infection

Intervention

Drug:
• 6 months of SAT
6 months of oral suppressive antibiotic therapy
• 12 months of SAT
12 months of oral suppressive antibiotic therapy
• Indefinite SAT
Indefinite oral suppressive antibiotic therapy

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland

Sponsors (6)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	NYU School of Medicine, OrthoCarolina Research Institute, Inc., OrthoMichigan, University of Arkansas, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reoperation for infection recurrence		2 years after patient enrollment
Secondary	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)
Secondary	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)