NCT03190421

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Loyola University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
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.

Timeline

• Start date: 2017-06-15
• Primary completion: 2020-03-30
• Completion: 2020-04-30
• First posted: 2017-06-16
• Last updated: 2020-06-16

Locations

1 site across 1 country: United States