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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Periprosthetic Joint Infection
Intervention / Treatment

-

Contacts and Locations

Baltimore

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Maryland, Baltimore,

Study Record Dates

2026-06