Study in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Occurring After Total Knee Arthroplasty (TKA)
Completed · Phase 1
Conditions studied: Joint Infection
In brief
The purpose of this study is to learn about the safety and effects of PLG0206 for treating periprosthetic joint infections (PJI) in conjunction with the DAIR (debridement, antibiotics and implant retention) surgical procedure for patients with periprosthetic joint infections (PJI) after total knee arthroplasty (TKA) .
Key facts
- Study ID
- NCT05137314
- Run by
- Peptilogics
- People needed
- 14
- Starts
- 2022-03-31
- Expected to finish
- 2024-03-19
- Last updated by the study team
- 2025-05-21
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with well-fixed prosthesis;
- Patients who have a pre- or intra-operative diagnosis of TKA-PJI
You may not qualify if…
- Patients for whom a DAIR procedure is not indicated;
- Patients with loose prosthesis and/or surgical treatment requiring removal of well-fixed, non-modular implants at screening;
- Patients with previous history or presence of osteomyelitis in the index limb;
- Patients who have uncontrolled diabetes mellitus;
- Patients with body mass index >50 kg/m2 at screening;
- Patients who are immunosuppressed;
- Patients who require therapeutic anticoagulation and/or antiplatelet therapy
Where it is running
- Stanford Hospital — Palo Alto, California, United States
- Gulfcoast Research — Sarasota, Florida, United States
- LifeBridge — Baltimore, Maryland, United States
- Brigham & Women's Hospital — Boston, Massachusetts, United States
- NYU Langone Orthopedic Hospital — New York, New York, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Ohio State University — Columbus, Ohio, United States
- Rothman — Philadelphia, Pennsylvania, United States
- Memorial Hermann Hospital — Houston, Texas, United States
- Michael E. DeBakey VA Medical Center — Houston, Texas, United States
- University of Utah Orthopaedic Center — Salt Lake City, Utah, United States
- WVU — Morgantown, West Virginia, United States
Full record on ClinicalTrials.gov
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