Randomized Open Label, Parallel Group, Controlled Study to Evaluate the Safety and Surgery Sparing Effect of Phage Therapy With Antibiotics for Patients With Prosthetic Joint Infections Who Are Candidates for Two Stage Exchange Arthroplasty
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Safety and tolerability of phage therapy
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 1 or 2 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus sp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae.
This study will also compare the safety and efficacy of phage therapy in conjunction with antibiotics versus standard of care (SOC) two-stage exchange arthroplasty plus 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
- 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.
- •Female patients of childbearing potential who agree to use contraception.
- •Candidate for a two-stage exchange arthroplasty.
- •Chronic prosthetic joint infection
排除标准
- •Prior history of prosthetic joint infections (PJI) of same joint treated surgically other than one prior Debridement Antibiotics and Implant Retention procedure
- •Soft tissue defect requiring reconstruction
- •Hardware misalignment or loosening
- •Active osteomyelitis
- •Septic shock or hemodynamic instability
- •Stage 4 or greater chronic kidney disease
- •Liver disease
- •Decompensated cirrhosis
- •Alcohol abuse or alcohol induced liver disease or non-alcoholic steatohepatitis
- •Decompensated heart failure
- •Any other clinically significant disease, per judgement of the investigator
- •Neutropenia (neutrophil count < 1000 cells/cubic mm), thrombocytopenia (platelets < 50,000/cubic mm) or aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) > 3 time the upper limit of normal
- •HIV, hepatitis C, hepatitis B infection
- •Positive drug screen
- •Receipt of chemotherapy, immunosuppressants or immune modulators
- •Anti-viral medication
- •Any known phage allergy
- •Breast feeding or pregnancy
结局指标
主要结局
Safety and tolerability of phage therapy
时间窗: Day 1 through Week 26
Incidence and type of adverse events and infusion reactions
次要结局
- Efficacy of phage therapy to prevent need for surgery in patients with hip/knee prosthetic joint infections.(6 weeks after completion of phage therapy)
- Efficacy of phage therapy in hip joint functionality as assessed by hip disability and osteoarthritis outcome questionnaire score (HOOS).(Week 26)
- Efficacy of phage therapy in knee joint functionality as assessed by knee injury and osteoarthritis outcome questionnaire score (KOOS).(Week 26)