Expanded Quantitative Urinary Culture (EQUC) vs Standard Culture (SUC) Techniques in the Clinical Care
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Infectious Disease, Urology, Urinary Tract Infections |
| Therapuetic Areas: | Immunology / Infectious Diseases, Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/5/2018 |
| Start Date: | June 15, 2017 |
| End Date: | December 30, 2019 |
| Contact: | Mary J Tulke, RN |
| Email: | mtulke@luc.edu |
| Phone: | 708-216-2067 |
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.
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.
laboratory improve the clinical care of women over standard urine culture techniques.
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.
"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.
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.
We found this trial at
1
site
2160 South 1st Avenue
Maywood, Illinois 60153
Maywood, Illinois 60153
(888) 584-7888
Phone: 708-216-2067
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