An Open-Label Multicenter Study to Evaluate the Safety and Efficacy of PhageBank™ Phage Therapy in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) for Patients With First Time Culture Proven Chronic Prosthetic Joint Infection
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- To evaluate safety and tolerability of phage therapy in adult patients undergoing DAIR for first time chronic prosthetic knee or hip infection
研究概览
简要总结
This study will test the feasibility of a regimen of intraoperative (IO) and intravenous (IV) PhageBank™ bacteriophage therapy in conjunction with a DAIR procedure to cure chronic prosthetic joint infection (PJI) without replacement of the prosthesis.
详细描述
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections of the hip or knee caused by 1 or 2 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae.
This study will compare the safety and efficacy of phage therapy in conjunction with standard of care antibiotics and a DAIR procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females ≥18 years of age.
- •Stopped or not received SAT for 2 weeks
- •Female patients of childbearing potential who agree to use contraception.
- •First time chronic prosthetic joint infection
- •Confirmed phage match
- •No anticipated need for long-term antibiotics
排除标准
- •Soft tissue defect requiring reconstruction.
- •Hardware misalignment
- •Additional orthopedic hardware in connection with the infected prosthesis.
- •Active infection
- •Unable to tolerate SAT
- •Septic shock or hemodynamic instability.
- •Chronic kidney disease
- •Liver disease
- •Decompensated heart failure.
- •Positive drug screen
- •Receiving chemotherapy
- •Immunocompromised
- •Antiviral treatment within 2 weeks prior to DAIR
- •Currently participating in another clinical trial
- •Known phage allergy
- •Pregnant/ breastfeeding
- •Lack of capacity to consent
结局指标
主要结局
To evaluate safety and tolerability of phage therapy in adult patients undergoing DAIR for first time chronic prosthetic knee or hip infection
时间窗: Day 1 through Week 24
Incidence of reactions to study treatment and discontinuation due to adverse events
Treatment success
时间窗: 13 months after DAIR
No recurrence or evidence of infection with the original pathogen at the same joint
次要结局
- No recurrence or evidence of infection for any reason(3, 6, 13, or 24 months after DAIR)