Bacteriophage Therapy for Staphylococcus Lugdunensis Prosthetic Joint Infection
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Clinical response to phage therapy as determined by participant's absence of physical clinical symptoms including wound drainage, swelling, erythema, pain, and fever.
研究概览
简要总结
This is a single-patient, phase I/II clinical trial that aims to evaluate the potential of a bacteriophage drug product to treat and prevent the recurrence of a Staphylococcus lugdunensis prosthetic joint infection of the hip. The patient has exhausted all conventional therapies, both surgical and medical, at considerable detriment to their quality of life. The treatment involves 2 intra-articular injections of bacteriophages into the joint and surrounding area and 14 days of intravenous phage therapy. The goal is to eliminate the infection and prevent further complications, providing a potential new treatment avenue for patients with difficult-to-treat infections.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of active chronic prosthetic joint infection
- •Causative bacteria is susceptible to bacteriophage therapy in vitro
- •History of multiple failed antibiotic and surgical interventions
排除标准
- •Stage 5 chronic kidney disease
- •Cirrhosis
- •A known allergy to phage products
- •Involvement in another clinical trial
- •Pregnancy
研究组 & 干预措施
Bacteriophage drug product
Five phage anti-Staphylococcus aureus bacteriophage cocktail
干预措施: Five phage anti-Staphylococcus aureus bacteriophage cocktail (Biological)
结局指标
主要结局
Clinical response to phage therapy as determined by participant's absence of physical clinical symptoms including wound drainage, swelling, erythema, pain, and fever.
时间窗: 1 year
Resolution of the infection, indicated by the absence of physical clinical symptoms including wound drainage, swelling, erythema, pain, and fever. The infection will be considered to be resolved if these physical clinical symptoms are absent.
次要结局
- Safety and tolerability of phage therapy determined by incidence of treatment-emergent adverse events(29 days)