Study in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Occurring After Total Knee Arthroplasty (TKA)

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to learn about the safety and effects of PLG0206 for treating acute periprosthetic joint infections (PJI) in conjunction with the DAIR (debridement, antibiotics and implant retention) surgical procedure for patients with acute periprosthetic joint infections (PJI) after total knee arthroplasty (TKA) .

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peptilogics
• Collaborators: Department of Health and Human Services; Wellcome Trust

Criteria

Inclusion Criteria:

• Patients with well-fixed prosthesis;

• Patients who have preoperative diagnosis of TKA-PJI ongoing no more than 4 weeks prior to study drug administration

Exclusion Criteria:

• 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;

• Presence of a sinus tract(s) at screening;

• Patients on chronic antibiotic therapy within 3 months of diagnosis of the PJI at screening;

• Patients with previous history or presence of osteomyelitis in the index limb;

• Patients who have uncontrolled diabetes mellitus;

• Patients who have anemia at screening;

• Patients with body mass index >40 kg/m2 at screening;

• Patients who are immunosuppressed;

• Patients who require therapeutic anticoagulation and/or antiplatelet therapy