跳至主要内容
临床试验/NCT04404855
NCT04404855已完成不适用

Randomized Clinical Trial Using Next Generation Microbial Sequencing to Direct Antibiotic Selection Before Kidney Stone Lithotripsy Using an Interprofessional Model

The University of Texas Health Science Center at San Antonio6 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2019年12月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
6
主要终点
Incidence of Infection Post Surgery

研究概览

简要总结

This is a randomized controlled clinical study evaluating the use of next-generation sequencing (NGS) to improve antibiotic prescribing before ureteroscopy or percutaneous nephrolithotomy.

详细描述

NGS will be performed on voided urine collected as routine care approximately 30 days prior to surgery. Results will be presented to Infectious Disease pharmacist within 48-72 hours to help select the most appropriate antibiotics, and independently as part of routine care, surgeons will choose the antibiotic that they would use in each case, while the Infectious Disease pharmacists would select their optimum choice. Approximately 220 subjects will be randomly assigned in a 1:1 ratio to receive either NGS antibiotic recommendation or standard of care (SOC) prophylaxis prescribed treatment. Subjects assigned to standard of care will have urine cultures sent for analysis, and the physician will choose antibiotics based on results as per usual practice. Subjects assigned to the NGS group, in addition to routine urine culture results, will have NGS urine culture results sent to an investigational drrug (ID) pharmacist, and recommendations will be shared with the physician to determine the antibiotic selection. The physician will ultimately decide the appropriate antibiotics to prescribe. Approximately 7-14 days after surgery, the research staff will conduct a telephone call to ask about any post-operative infections, complications, and any additional antibiotics that were prescribed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Patients planning to undergo kidney or bladder stone removal surgery using endoscopy including ureteroscopy and percutaneous nephrolithotomy or any other transurethral procedure
  • Age 18 or older
  • Able to give informed consent

排除标准

  • Unwilling or unable to provide informed consent
  • Age < 18
  • Does not meet inclusion criteria

结局指标

主要结局

Incidence of Infection Post Surgery

时间窗: One to two weeks after surgery (approximately 100 days from baseline)

Number of participants that develop post surgical infection

次要结局

  • Number of Participants for Whom Additional Antibiotics Were Selected(Within 30 days of urine culture and date of surgery (approximately 100 days from baseline))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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