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

NCT03190421 | Completed DMC

• 1 other identifier: 209545
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• Compare UTI symptom resolution rates in women with symptoms of UTI who are treated based on EQUC versus SUC results.

  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.

  4 weeks

Secondary Outcomes (2)

• Revise the EQUC treatment algorithm.

  6 months

• Identify the symptom profile associated with specific organisms.

  1 year

Study Arms (2)

Expanded Urinary Culture (EQUC)

EXPERIMENTAL

Participants in this arm will receive the expanded urine culture

Diagnostic Test: Expanded Urinary Culture

Standard Urine Culture (SUC)

ACTIVE COMPARATOR

Participants in this arm will receive the standard urine culture

Diagnostic Test: Standard Urine Culture (SUC)

Interventions

Expanded Urinary Culture 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.

Expanded Urinary Culture (EQUC)

Standard Urine Culture (SUC) 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.

Standard Urine Culture (SUC)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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").

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (3)

• KASS EH. Asymptomatic infections of the urinary tract. Trans Assoc Am Physicians. 1956;69:56-64. No abstract available.

  PMID: 13380946 RESULT

• 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.

  PMID: 86778 RESULT

• 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.

  PMID: 22457796 RESULT

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Elizabeth Mueller, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Professor

Model Details: Expanded Quantitative Urinary Culture (EQUC) versus Standard Culture (SUC) Techniques

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 16, 2017
• Study Start: June 15, 2017
• Primary Completion: March 30, 2020
• Study Completion: April 30, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)