WithdrawnNot Applicable

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

Stopped: No participants enrolled.

United States0Started 2024-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Reoperation for infection recurrence

Timeframe: 2 years after patient enrollment

Trial details

NCT IDNCT05495815

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02