Bacteriophage Therapy for Morganella Morganii Prosthetic Joint Infection
试验速览
- 阶段
- 1 期
- 状态
- 进行中（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 symptoms
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 Morganella morganii 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
Open Label Arm
Bacteriophage drug product
干预措施: phage therapy (Biological)
结局指标
主要结局
Clinical response to phage therapy as determined by participant's absence of physical symptoms
时间窗: 1 year
Resolution of the infection, indicated by the absence of clinical symptoms such as wound drainage, swelling, erythema, pain, and fever. This will be determined by a questionnaire and monthly assessments by a Infectious Disease physician.
次要结局
- Safety and tolerability of phage therapy determined by incidence of treatment-emergent adverse events(29 days)