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

NCT05495815 | Withdrawn

• 1 other identifier: Maryland
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Periprosthetic Joint Infection; Antibiotic Suppression

Outcome Measures

Primary Outcomes (1)

• Reoperation for infection recurrence

  2 years after patient enrollment

Secondary Outcomes (2)

• 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)

Study Arms (3)

6 months of SAT

ACTIVE COMPARATOR

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

Drug: 6 months of SAT

12 months of SAT

ACTIVE COMPARATOR

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

Drug: 12 months of SAT

Indefinite SAT

ACTIVE COMPARATOR

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

Drug: Indefinite SAT

Interventions

6 months of SAT DRUG

6 months of oral suppressive antibiotic therapy

6 months of SAT

12 months of SAT DRUG

12 months of oral suppressive antibiotic therapy

12 months of SAT

Indefinite SAT DRUG

Indefinite oral suppressive antibiotic therapy

Indefinite SAT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

diamine N-acetyltransferase

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Chief of Adult Reconstruction

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 10, 2022
• Study Start: December 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)