A Phase I/II Study of Bacteriophage Therapy to Evaluate Safety, Tolerability, and Efficacy of Targeted "Personalized" Bacteriophage Treatments in Patients With Bacterial Infection of the Urinary Tract
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 16
- 主要终点
- Identify ideal bacteriophage treatment regimens based on improvements in disease control rates
研究概览
简要总结
This is a phase I/II trial designed to evaluate bacteriophage therapy in patients with urinary tract infections.
详细描述
This study will evaluate the safety and efficacy of bacteriophage therapy in patients with urinary tract infection (UTI). Patients to be enrolled will have urinary tract infections due to E. coli and K. pneumoniae. This will include asymptomatic patients with neurogenic bladder and symptomatic patients with complicated urinary tract infections who are at risk of UTI recurrence. Patients will be followed for bacterial clearance or recurrence of urinary tract infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Patient will be randomized to receive either active phage or placebo treatment.
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.
- •Male patients must agree not to donate sperm up for one month.
- •English-speaking.
排除标准
- •Stage 4 or greater chronic kidney disease (CKD).
- •Abnormal liver function tests >3×upper limit of normal (ULN).
- •Other conditions which could confound study results.
- •Body mass index of > 40 or weight less than 50 kg.
- •Known allergy to phage products.
- •Pregnant and/or breastfeeding.
- •Immunocompromised.
- •Need for antiviral medication.
- •History of severe autonomic dysreflexia.
结局指标
主要结局
Identify ideal bacteriophage treatment regimens based on improvements in disease control rates
时间窗: baseline
Microbiological eradication of target pathogen identified at baseline
次要结局
- Assess the tolerability of bacteriophage therapy(At least 56 days)
- Assess the safety of bacteriophage therapy(At least 56 days)