A Randomized Pilot and Feasibility Study of a cultuRE-Directed Approach to Urinary traCT Infection Symptoms in Older womeN: a Mixed Methods Evaluation - the REDUCTION Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Eligible Subjects That Were Enrolled in the Study
研究概览
简要总结
To evaluate the feasibility of recruiting eligible subjects into a randomized trial of a culture-directed versus empiric antibiotic strategy for patient-reported urinary tract infection symptoms in older women and the adherence to study procedures.
详细描述
To evaluate A) the feasibility of recruiting eligible subjects into a randomized trial of a culture-directed versus empiric antibiotic strategy for patient-reported urinary tract infection (UTI) symptoms in older women and B) the adherence to study procedures. We will recruit and enroll women with a history of recurrent UTI (rUTI) from the Women's Center for Bladder and Pelvic Health and the University of Pittsburgh's Clinical and Translational Science Institute (CTSI) Pitt+Me® Research Registry. Once enrolled and randomized, women will be followed for a total of 28 days to document both clinical resolution at day 7 from symptom onset and adverse events. H1) Enrolling a total of 70 subjects in <1 year (at least 10% of eligible patients) will demonstrate feasibility of recruitment and H2) Documenting at least 70% patient compliance with study procedures will confirm patient adherence to study protocol. Exploratory Aim: To explore the safety of a culture-directed UTI treatment strategy and preliminary secondary outcomes of assigned treatments. H1) There will be an overall low number of adverse events and H2) Preliminary outcome data will help power future trial.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female biologic Sex
- •Age ≥65 years old
- •History of recurrent UTI per patient report of greater than 2 UTIs in the last 6 months or 3 UTIs in the last year
- •Patient reported UTI defined as:
- •Dysuria, increased urinary urgency/frequency and/or suprapubic pain
排除标准
- •Male biologic sex
- •Age <65 years old
- •History of augmentation cystoplasty or cystectomy
- •Currently performing clean intermittent self-catheterization
- •Current indwelling foley catheter
- •Urinary tract instrumentation (i.e., cystourethroscopy, foley catheter placement) in the last 30 days
- •Undergoing treatment for malignancy
- •History of either confirmed or patient reported pyelonephritis and/or urosepsis
- •Cirrhosis and/or end stage liver disease
- •Chronic kidney disease with most recent estimated glomerular filtration rate <50 ml/min
- •Dementia and/or currently reside in skilled nursing facility
- •Current high-dose chronic steroids (>20mg/day of prednisone)
- •Previous solid organ transplant
- •Provider concern for pyelonephritis and/or sepsis (i.e., fevers)
- •Unwilling or unable to comply with study procedures
研究组 & 干预措施
Culture-directed antibiotic
Participants will be directed to refrain from taking antibiotics until results of urine culture are reported, which is expected within 48-72h.
干预措施: Antibiotics (Drug)
Empiric antibiotic
Antibiotic Protocol. For participants in the empiric Rx arm, we will choose an antibiotic with consideration of patient reported allergies, current medications and current Infectious Disease Society of American (IDSA) guidelines. If there is a contraindication to the first antibiotic on the list they will progress to the next option until a suitable selection is achieved.
干预措施: Antibiotics (Drug)
结局指标
主要结局
Eligible Subjects That Were Enrolled in the Study
时间窗: Through study completion, an average of 17.5 months
Number and proportion of eligible subjects that were enrolled in the study
次要结局
- Number of Persons That Were Screened for Participation(Through study completion, an average of 17.5 months)
- Proportion of Persons Screened Who Met Inclusion/Exclusion Criteria(30 days)
- Proportion of Persons Screened Who Declined Participation or Were Ineligible(30 days)
- Proportion of Enrolled Participants That Completed Electronic Surveys(30 days)
- Proportion of Participants Enrolled Who Completed the Study(30 days)
- Monthly Enrollment Rate(Through study completion, an average of 17.5 months)
- Proportion of Participants in the Culture-directed Arm That Acquired Off-protocol Antibiotics for Their Symptoms(30 days)
- Proportion of Enrolled Participants That Completed All Study Procedures(30 days)
- Proportion of Enrolled Participants That Took Alternative Agents for Management of Symptoms(30 days)
研究者
Megan Bradley
Assistant Professor
University of Pittsburgh