Rapid PCR to Guide Antibiotic Therapy at the Time of Prostate Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Results of rapid qPCR to determine standard of care antibiotic prophylaxis for prostate biopsy.
研究概览
简要总结
The study is a randomized controlled trial. Subjects are randomly assigned 1:1 to receive either rapid multiplex qPCR (intervention) prior to standard of care prostate biopsy or standard of care (control) prostate biopsy. The subjects will have a rectal culture swab performed prior to the prostate biopsy. One rectal culture swab will be used for rapid multiplex qPCR and the other swab will be sent to microbiology for a standard culture. The subjects randomized to the intervention group will have the qPCR results shared with the physician to determine if additional standard of care antibiotics are needed at time of standard of care prostate biopsy. The subjects randomized to the control group will not have the qPCR results shared with the physician to determine if additional standard of care antibiotics are needed at time of standard of care prostate biopsy. Approximately, 10 days after the prostate biopsy, the research staff will conduct a chart review and/or telephone call to ask about any prostate biopsy infections and complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Investigator)
盲法说明
The rPCR results will be provided to the clinical provider for the Interventional group participants. The rPCR results will not be provided to the clinic provider for the control group participants.
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Be able to give informed consent
- •Be age 50 or older
- •Recommended to undergo a prostate biopsy
- •No allergy or side effect to fluoroquinolone antibiotics
- •No history of prostate biopsy infection
- •No hepatic or renal insufficiency in which fluoroquinolone antibiotics are contraindicated.
排除标准
- •Unable to give informed consent
- •Age < 50
- •Not recommended to have prostate biopsy
- •Allergic to or have side effects to fluoroquinolone antibiotics
- •History of prostate biopsy infection
- •Hepatic or renal insufficiency in which fluoroquinolones antibiotics are contraindicated.
结局指标
主要结局
Results of rapid qPCR to determine standard of care antibiotic prophylaxis for prostate biopsy.
时间窗: Day of prostate biopsy
Reduction in dual antibiotic prophylaxis in the intervention vs.usual care groups.
次要结局
- Determine if rapid qPCR test results in longer patient wait times.(Day of prostate biopsy)
- Determine if rPCR results and standard rectal culture results are the same.(1 week)
