Phage Therapy for the Treatment of Urinary Tract 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
- 2
- 主要终点
- Safety and Tolerability
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 bacteriophage therapy to treat and prevent the recurrence of a drug-resistant urinary tract infection with serious long-term effects. This study will follow a minimally invasive phage therapy approach consisting of oral, topical (opening of the urethra) and bladder installations of a 3-phage cocktail comprised of HP3, HP3.1 and ES19.
详细描述
This is a single-patient, phase I/II clinical trial that aims to evaluate the potential of bacteriophage therapy to treat and prevent the recurrence of a drug-resistant urinary tract infection. This study will follow a minimally invasive phage therapy approach consisting of oral, topical and bladder installations of a 3-phage cocktail comprised of HP3, HP3.1 and ES19.
Oral and bladder installation of bacteriophages will be administered on day 1 - and potentially day 7 depending on day 5 urine and stool lab results - and a topical preparation will be applied externally to the urethra for 30-minutes on days 1 to 3. However, if the participant is still experiencing mild symptoms on day 5, systemic antibiotics will be administered in combination with phage therapy.
The primary objective is to determine the safety and tolerability of minimally invasive bacteriophage therapy for treating recurrent urinary tract infections with severe long-term effects.
The secondary objective is to evaluate the 90-day clinical and microbial response to the minimally invasive administration of bacteriophages for recurrent urinary tract infections with severe long-term outcomes.
The total duration of participant involvement is 2 years, while the study is estimated to be completed in 3 years.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of recurrent chronic urinary tract infections with severe long term effects
- •Can speak and understand English
- •Willing to follow the protocol
排除标准
- •Stage 5 chronic kidney disease
- •Abnormal liver function tests
- •A urinary stent or chronic indwelling catheterization
- •A known allergy to phage products
- •Pregnancy
- •Involved in another clinical trial
研究组 & 干预措施
Open Label Arm
干预措施: Phage Therapy (Biological)
结局指标
主要结局
Safety and Tolerability
时间窗: 90 Days
The primary objective is to determine the safety and tolerability of minimally invasive bacteriophage therapy for treating recurrent urinary tract infections with severe long-term effects. These will be assessed through the use of a daily symptom questionnaire, adverse events (AEs), clinical and research laboratory results.
次要结局
- Clinical and microbial response(90 Days)