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

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Loyola University

Status

Completed

Conditions

Urinary Tract Infections

Treatments

Diagnostic Test: Expanded Urinary Culture
Diagnostic Test: Standard Urine Culture (SUC)

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

225 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

225 participants in 2 patient groups

Expanded Urinary Culture (EQUC)
Experimental group
Description:
Participants in this arm will receive the expanded urine culture
Treatment:
Diagnostic Test: Expanded Urinary Culture
Standard Urine Culture (SUC)
Active Comparator group
Description:
Participants in this arm will receive the standard urine culture
Treatment:
Diagnostic Test: Standard Urine Culture (SUC)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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