Bacteriophages for Treating Urinary Tract Infections in Patients Undergoing Transurethral Resection of the Prostate: A Randomized, Placebo-controlled, Double-blind Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Normalisation of urine culture
研究概览
简要总结
Urinary tract infections are among the most prevalent microbial diseases and their financial burden on society is substantial. The use of bacteriophages against bacterial pathogens has gained over the last years a renewed interest, because of the continuing increase in antibiotic resistance worldwide. Thus, the aim of this study is to investigate the efficacy of intravesical bacteriophage treatment to normalize urine culture compared to intravesical placebo or standard antibiotic treatment in a randomized controlled trial following a pilot phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Patients with urinary tract infections who are scheduled for transurethral resection of the prostate with urine culture (taken by mid-stream urine; or from the existing transurethral or suprapubic catheter) ≥104 colony forming units /mL of predefined uropathogens, including Enterococcus spp., Escherichia coli, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus spp., and Streptococcus spp. and lower urinary tract symptoms such as urgency, frequency, dysuria, increased number of incontinence episodes
- •Written informed consent.
排除标准
- •Fever >38°C
- •CRP >100mg/L
- •Acute prostatitis
- •Concomitant fungal urinary tract infection
- •Current antibiotic treatment or antibiotic treatment within the last 7 days (exceptions: subjects with an active catheter associated urinary tract infection who have received prior antibiotics may be enrolled provided a minimum of 48 hours has elapsed between the last dose of the prior antibiotic and the time of obtaining the baseline urine specimen. Subjects receiving current antibiotic prophylaxis for catheter associated urinary tract infection who present signs and symptoms consistent with an active new catheter associated infection may be enrolled provided all other eligibility criteria are met including obtaining a pre-treatment qualifying baseline urine culture)
- •Any rapidly progressing disease or immediately life-threatening illness including but not limited to: acute hepatic failure, respiratory failure, and septic shock
- •No informed consent
研究组 & 干预措施
Anbiotica
干预措施: Antibiotics (Drug)
Bacteriophages
干预措施: PYO Phage (Biological)
Placebo
干预措施: Sterile bacteriology media (Other)
结局指标
主要结局
Normalisation of urine culture
时间窗: 7 days after treatment
Success of intravesical treatment, defined as normalization of urine culture (no evidence of bacteria, i.e. \<104 colony forming units/mL) after 7 days of bacteriophage, placebo, or antibiotic treatment
次要结局
- Urine culture(Baseline and 7 days after treatment)
- Bladder diary(Baseline and 7 days after treatment)
- Pain diary(Baseline and 7 days after treatment)
- IPSS questionnaire(Baseline and 7 days after treatment)
研究者
Thomas Kessler
Dr.
Balgrist University Hospital