NCT04831840TerminatedNot Applicable
Is PCR Amplification More Sensitive Than Urine Cultures in Diagnosing Urinary Tract Infections in Patients With Recurrent Bladder Infections?
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Miami
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Proportion of patients negative for repeat testing
Study Overview
Brief Summary
The primary objective is to determine if polymerase chain reaction (PCR) (UTIP™) is more sensitive in identifying urinary tract infections (UTI's) than standard urine cultures.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 y/o-90 y/o
- •Able to consent
- •Group A only: Recurrent UTI (2 UTIs in 6 months)
- •Group B only: No history of recurrent UTIs
Exclusion Criteria
- •Pelvic radiation
- •Urinary retention (>200 ml residual)
- •Greater than Stage 2 prolapse
- •Renal calculi
- •Immunosuppressed
- •Neurologic disorder with significant bladder impairment
- •No current UTI via dip stick
Outcomes
Primary Outcomes
Proportion of patients negative for repeat testing
Time Frame: Up to 4 weeks
The proportion of negative patient on repeat testing of urine samples.
Proportion of uropathogens
Time Frame: Day 1
The proportion of uropathogens found on PCR versus urine culture from urine samples.
Secondary Outcomes
No secondary outcomes reported
Investigators
Laura Martin
Assistant Professor
University of Miami
Study Sites (2)
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