Evaluating the best duration for antibiotic therapy after joint infection treatment
Randomized Clinical Trial Determining Proper Duration of Suppressive Antibiotic Therapy After Total Joint Arthroplasty Debridement, Antibiotics, and Implant Retention
This study is testing how long people with joint infections should take antibiotics after treatment to see which duration works best for preventing complications and infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 438 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05495815 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the optimal duration of oral suppressive antibiotic therapy (SAT) following debridement, antibiotics, and implant retention (DAIR) for patients with acute periprosthetic joint infection (PJI). It aims to assess the effects of different SAT durations—6 months, 12 months, and indefinite—on adverse drug reactions, reoperation rates due to infection, and the risk of antibiotic resistance. The study is a prospective randomized controlled multicenter trial, building on previous findings from a pilot study with a focus on improving patient outcomes in total joint arthroplasty. By evaluating a larger and more homogeneous patient cohort, the trial seeks to provide clearer insights into the sequelae of SAT.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 who have undergone DAIR for acute periprosthetic joint infection and have been on postoperative oral SAT for at least 3 months.
Not a fit: Patients who have undergone aseptic revision surgery or those who did not receive postoperative SAT will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of antibiotic therapy for patients recovering from joint infections, potentially reducing reoperation rates and antibiotic resistance.
How similar studies have performed: Previous studies have shown varying results regarding the duration of antibiotic therapy, indicating that this approach is both relevant and necessary for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland
- University of Maryland — Baltimore, Maryland, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.