Expanded Quantitative Urinary Culture (EQUC) vs Standard Culture (SUC) Techniques in the Clinical Care
- Conditions
- Urinary Tract Infections
- Interventions
- Diagnostic Test: Standard Urine Culture (SUC)Diagnostic Test: Expanded Urinary Culture
- Registration Number
- NCT03190421
- Lead Sponsor
- Loyola University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 225
- 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").
- 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
- Men
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Urine Culture (SUC) Standard Urine Culture (SUC) Participants in this arm will receive the standard urine culture Expanded Urinary Culture (EQUC) Expanded Urinary Culture Participants in this arm will receive the expanded urine culture
- Primary Outcome Measures
Name Time Method Compare UTI symptom resolution rates in women with symptoms of UTI who are treated based on EQUC versus SUC results. 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.
- Secondary Outcome Measures
Name Time Method Revise the EQUC treatment algorithm. 6 months The EQUC treatment algorithm was based on known uropathogens that we had previously identified as most likely to be symptomatic. During the course of this work we may identify other pathogens that are present and causing symptoms. These organisms will be identified and added to the treatment algorithm. This interim analysis is planned and was part of the statistical calculations to determine sample size.
Identify the symptom profile associated with specific organisms. 1 year Using the UTISA questionnaire, we will perform a symptoms association study with specific bacteria.
Trial Locations
- Locations (1)
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States