A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of APT Phage Bank Phage Therapy Versus Placebo in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) in Subjects With Chronic Prosthetic Joint Infection (PJI)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 10
- 主要终点
- To evaluate the safety and tolerability of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI
研究概览
简要总结
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
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 at least 1 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, or Klebsiella pneumoniae.
This study will compare the safety and efficacy of DAIR procedure + Phage Therapy + Antibiotics versus DAIR procedure + Placebo + Antibiotics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-Blind
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
- •Recurrent PJI of the knee or hip
- •Female patients of childbearing potential who agree to use contraception.
- •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 (other than PJI) requiring long term IV antibiotics
- •Unable to tolerate SAT
- •Septic shock or hemodynamic instability
- •Stage 4 or greater chronic kidney disease
- •Liver disease
- •Decompensated heart failure
- •Positive drug screen
- •Receiving chemotherapy
- •Immunocompromised
- •Treatment with antiviral medication within 2 weeks prior to randomization
- •Currently participating in another clinical trial
- •Known phage allergy
- •Pregnant/ breast feeding
- •Lack of capacity to consent
研究组 & 干预措施
DAIR + Phage Treatment + Antibiotics
Phage therapy will be administered in conjunction with antibiotic treatment.
干预措施: Bacteriophage (Drug)
DAIR + Placebo + Antibiotics
Placebo will be administered in conjunction with antibiotic treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI
时间窗: Day 1 through Week 24
Incidence of reactions to study treatment and discontinuation due to adverse events
To evaluate the efficacy of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI
时间窗: Day 1 through 24 months
Time to recurrence or evidence of infection with the original pathogen at the same joint
次要结局
- Treatment success(Day 1 through 12 months)
- No recurrence or evidence of infection for any reason(12 months after DAIR)