The Use of Expanded Quantitative Urinary Culture (EQUC) Versus Standard Culture (SUC) Techniques in the Clinical Care of Women With Symptoms of Urinary Tract Infections.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- Compare UTI symptom resolution rates in women with symptoms of UTI who are treated based on EQUC versus SUC results.
研究概览
简要总结
This purpose of this study is to see if expanded urine culture techniques used in the laboratory improve the clinical care of women over standard urine culture techniques.
详细描述
The investigators request permission to recruit 225 women who respond "yes" to the question "do you feel you have a urinary tract infection". All participants will provide baseline urine specimens obtained by transurethral catheter (to avoid vulvo-vaginal contamination) and will complete a UTISA questionnaire to assess their current urinary tract symptoms. Participants will be randomized to the SUC treatment algorithm or the EQUC treatment algorithm. Treating physicians will receive either the SUC results or the EQUC results from the clinical laboratory and the results will be part of their clinical record. Treating physicians will follow the Loyola FPMRS treatment algorithm. Women in the study will also give consent for us to contact them using email, text messaging or phone call within 7-10 days after "treatment plan" has been implemented. The treatment plan options will include no treatment if the culture results show no pathogenic bacteria. All participants will be queried 7-10 days after their treatment plan (by email or text) "do you feel you continue to have a urinary tract infection". Women who respond "yes' will be asked to return for a second urine specimen which is our standard protocol. The second urine specimen will be analyzed using EQUC culture techniques only. Again, a treatment plan will be developed by the attending physician and the patient participant will be queried 7-10 days after the plan is implemented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A "yes" answer to the screening question "do you feel you have a UTI"?
- •Non-pregnant women ages 18 years or older
- •Agreement to respond to a text or email question 7-10 days after treatment plan for their UTI (note: the treatment plan may include "no treatment").
排除标准
- •Women currently on antibiotics
- •Patients who cannot communicate or read in English
- •Patients under the age of 18
- •Pregnant patients
- •Women with an indwelling catheter and intermittent self-catheterization
- •Urine obtained via the "clean catch method" (i.e. voided urine)
- •Women who refuse to be catheterized
- •Women who cannot or will not agree to respond to an email or text message 7-10 days after treatment plan is initiated.
结局指标
主要结局
Compare UTI symptom resolution rates in women with symptoms of UTI who are treated based on EQUC versus SUC results.
时间窗: 4 weeks
Using the FPMRS treatment algorithms (see appendix I \& II Standard Urine Culture Treatment and Expanded Urine Culture Treatment Algorithms), attending physicians will treat participants based on their randomization to EQUC versus SUC. Following a 3-5 day standard course of treatment (which may include no antibiotics if the culture is negative), participants will be queried 7-10 days "do you continue to have UTI symptoms". Women who report "no" will be categorized as successful treatment, women who respond "yes" will be categorized as treatment failures.
次要结局
- Revise the EQUC treatment algorithm.(6 months)
- Identify the symptom profile associated with specific organisms.(1 year)
研究者
Elizabeth Mueller
M.D., Professor
Loyola University