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

Trial ID or NCT#

NCT05137314

Status

not recruiting iconNOT RECRUITING

Purpose

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) .

Official Title

A Phase 1b Open-Label, Dose-Escalating Study to Evaluate the Safety and Tolerability of PLG0206 in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Occurring After Total Knee Arthroplasty (TKA)

Eligibility Criteria

Ages Eligible for Study: 18 to 79
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Patients with well-fixed prosthesis;* Patients who have a pre- or intra-operative diagnosis of TKA-PJI
Exclusion Criteria:
  1. * 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
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Investigator(s)

Derek Amanatullah
Derek Amanatullah
Arthritis and joint replacement surgeon
Associate Professor of Orthopaedic Surgery

Contact us to find out if this trial is right for you.

Contact

David Huang, MD
(936) 577-5770

View on ClinicalTrials.gov