Expanded Quantitative Urinary Culture (EQUC) vs Standard Culture (SUC) Techniques in the Clinical Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2020-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Expanded Quantitative Urinary Culture (EQUC) versus Standard Culture (SUC) Techniques

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Expanded Urinary Culture (EQUC)

Participants in this arm will receive the expanded urine culture

Group Type EXPERIMENTAL

Expanded Urinary Culture

Intervention Type DIAGNOSTIC_TEST

involves the inoculation of 100X (0.1mL) more urine onto diverse types of media (BAP, chocolate agar, colistin and nalidixic acid (CNA) agar, CDC anaerobe 5% BAP) with incubation in more environments and temperatures (5% CO2 at 35°C for 48 h, aerobic conditions at 35°C and 30°C for 48 h, Campy gas mixture (5% O2, 10% CO2, 85% N) or anaerobic conditions at 35°C for 48 h). The level of detection for EQUC is 10 CFU/mL, represented by 1 colony of growth on any of the plates. EQUC is designed to isolate a broad array of Gram-negative and Gram-positive bacteria, including anaerobes and fastidious bacteria that grow slowly.

Standard Urine Culture (SUC)

Participants in this arm will receive the standard urine culture

Group Type ACTIVE_COMPARATOR

Standard Urine Culture (SUC)

Intervention Type DIAGNOSTIC_TEST

involves inoculation of 0.001 mL of urine onto 5% sheep blood agar plate (BAP) and MacConkey agar plate with the plates being incubated aerobically at 35°C for 24 h. Thus, the level of detection for standard culture is 103 CFU/mL, represented by 1 colony of growth on either plate. Standard culture is designed specifically to grow Gram-negative rods, especially UPEC.

Interventions

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Expanded Urinary Culture

involves the inoculation of 100X (0.1mL) more urine onto diverse types of media (BAP, chocolate agar, colistin and nalidixic acid (CNA) agar, CDC anaerobe 5% BAP) with incubation in more environments and temperatures (5% CO2 at 35°C for 48 h, aerobic conditions at 35°C and 30°C for 48 h, Campy gas mixture (5% O2, 10% CO2, 85% N) or anaerobic conditions at 35°C for 48 h). The level of detection for EQUC is 10 CFU/mL, represented by 1 colony of growth on any of the plates. EQUC is designed to isolate a broad array of Gram-negative and Gram-positive bacteria, including anaerobes and fastidious bacteria that grow slowly.

Intervention Type DIAGNOSTIC_TEST

Standard Urine Culture (SUC)

involves inoculation of 0.001 mL of urine onto 5% sheep blood agar plate (BAP) and MacConkey agar plate with the plates being incubated aerobically at 35°C for 24 h. Thus, the level of detection for standard culture is 103 CFU/mL, represented by 1 colony of growth on either plate. Standard culture is designed specifically to grow Gram-negative rods, especially UPEC.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No