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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Maryland
Baltimore, Maryland 21201
Contact:
Sumon Nandi
617-717-8065
sumon.nandi@som.umaryland.edu

More Details

Status
Recruiting
Sponsor
University of Maryland, Baltimore

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.