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)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 12
- 主要终点
- The percentage of treatment emergent AEs
研究概览
简要总结
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) .
详细描述
Peptilogics, Inc. is developing PLG0206 for the treatment of PJIs. PLG0206 is an engineered antibacterial peptide (EAP) based on naturally-occurring antimicrobial peptides (AMPs). Recent work on PLG0206 has documented that PLG0206 is a highly effective anti-biofilm agent, in addition to its established activity against planktonic staphylococcus, both in vitro and in a murine animal model of PJI.
PLG0206 will be investigated in this study for treatment of PJI in conjunction with the DAIR procedure followed by the 6-week course of antimicrobial therapy that is standard-of-care (SOC) in this indication.
Patients will be followed for approximately 1 year post treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with well-fixed prosthesis;
- •Patients who have a pre- or intra-operative diagnosis of TKA-PJI
排除标准
- •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
研究组 & 干预措施
3 mg/mL PLG0206
administered intraoperatively by local irrigation
干预措施: PLG0206 (Drug)
10 mg/mL PLG0206
administered intraoperatively by local irrigation
干预措施: PLG0206 (Drug)
结局指标
主要结局
The percentage of treatment emergent AEs
时间窗: approximately 1 year
the safety and tolerability of PLG0206 administered via an irrigation solution for the treatment of a PJI occurring after TKA during DAIR.
次要结局
未报告次要终点