Prospective, Single-Center, Single-Arm, Pre-Post Self-Controlled Study Evaluating the Efficacy and Safety of Bacteriophage Therapy in Orthopedic Implant-Associated Infections
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Bacterial eradication rate after bacteriophage therapy
研究概览
简要总结
A Prospective, Single-Center, Single-Arm Clinical Study with a Pre-Post Self-Controlled Design Evaluating the Efficacy and Safety of Bacteriophage Therapy for Refractory Orthopedic Implant-Associated 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
- 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
- •Known allergy or hypersensitivity to bacteriophages or any components of the bacteriophage preparation;
- •Pregnant or breastfeeding women;
- •Participation in another interventional clinical trial within the study period;
- •Lack of feasible routes of administration other than intravenous injection;
- •Patients deemed unsuitable for participation in this study by the investigator;
- •Inability or unwillingness of the subject to comply with study procedures.
排除标准
- •Withdrawal of informed consent by the participant at any time during the study;
- •Occurrence of serious adverse events related to bacteriophage therapy that, in the investigator's judgment, necessitate discontinuation of treatment.
研究组 & 干预措施
Bacteriophage Therapy
To evaluate the infection control effect of bacteriophage therapy in treatment of refractory orthopedic implant-associated infections
干预措施: bacteriophage preparation (Biological)
结局指标
主要结局
Bacterial eradication rate after bacteriophage therapy
时间窗: Within 7 days after initiation of therapy
The primary outcome of this study is the eradication of the target pathogen following bacteriophage treatment. Microbiological samples from the infection site will be collected before treatment and on days 1, 3, 5, and 7 after initiation of bacteriophage therapy for bacterial culture and identification. Bacterial eradication is defined as two consecutive negative cultures for the target pathogen after completion of bacteriophage therapy. If the target bacteria are still detected on day 3 or day 5, a reassessment will be performed to determine whether an additional cycle of bacteriophage therapy is required
次要结局
- Clinical and inflammatory response improvement(Within 1 month after treatment)