Clinical trial NCT03190421: Expanded Quantitative Urinary Culture (EQUC) vs Standard Culture (SUC) Techniques in the Clinical Care
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 225
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Expanded Quantitative Urinary Culture (EQUC) versus Standard Culture (SUC) Techniques
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* 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").

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Compare UTI symptom resolution rates in women with symptoms of UTI who are treated based on EQUC versus SUC results.
timeFrame: 4 weeks
Secondary outcomes:
measure: Revise the EQUC treatment algorithm.
timeFrame: 6 months
measure: Identify the symptom profile associated with specific organisms.
timeFrame: 1 year
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Loyola University
name: Elizabeth Mueller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: KASS EH. Asymptomatic infections of the urinary tract. Trans Assoc Am Physicians. 1956;69:56-64. No abstract available.
citation: Maskell R, Pead L, Allen J. The puzzle of "urethral syndrome": a possible answer? Lancet. 1979 May 19;1(8125):1058-9. doi: 10.1016/s0140-6736(79)92953-2.
citation: Yuan S, Cohen DB, Ravel J, Abdo Z, Forney LJ. Evaluation of methods for the extraction and purification of DNA from the human microbiome. PLoS One. 2012;7(3):e33865. doi: 10.1371/journal.pone.0033865. Epub 2012 Mar 23.