Rapid UTI Diagnostics in Lower Urinary Tract Dysfunction Among Catheter Users

Summary

Patients who seek care through MedStar National Rehab Hospital's clinic believing they have a UTI will be enrolled in this trial. They will be pre-screened after consent according to a standard-of-care clinical symptom measure called the USQNB. If determined by this measure to be at high or moderate likelihood of having a UTI, they will be assigned to the presumed UTI arm and instructed to come to the clinic to provide a urine sample and undergo standard diagnostic testing to determine if a UTI is present. Those not assigned to the presumed UTI arm at this phase are assigned to the presumed no UTI arm and do not present to the clinic. These tests include a repeated questionnaire about the UTI symptoms they are experiencing and collection of a urine sample from a freshly changed indwelling catheter for standard clinical urinalysis testing and culture. Based upon the clinical guideline-informed results of these standard clinical tests, patients will be assigned into one of two potential arms (suspected UTI or suspected non-UTI) based on whether or not they are diagnosed with UTI at that visit.

Arm 1 (presumed UTI) participants will have a second urine sample collected at the time of the visit from the used indwelling catheter bag in addition to the freshly changed catheter sample, and both will be divided into three portions: one for repeat clinical tests and culture, one for assessment using the experimental Jiddu device, and one to be stored for potential future studies. The study doctor will then determine antibiotic choice according to standard clinical decision making and record, but not prescribe, that choice. Once results are obtained from the samples sent for experimental analysis, the study doctor will use those results in addition to their best clinical judgement and all standard available clinical evidence to choose the antibiotic treatment. Arm 1 participants will then complete urine symptom surveys at day 3 and 7 during antibiotic use to determine effectiveness of antibiotics prescribed. In the event of standard urine culture results differing from the Jiddu-produced pooled AST values rescue antibiotic consisting of the antibiotic choice based on best clinical judgement using this newly available evidence will be used to ensure safety and this survey clock will restart and include a USQNB on day 10.

Arm 2 participants will repeat the urinary symptoms questionnaire 3 and 7 days after their initial completion to see if their symptoms have changed and would allow them to qualify. If they remain unqualified at 7 days, they will be instructed to fill out another survey the next time they think they have a UTI. This process will repeat until they either qualify to become an Arm 1 participant or 6 months have passed since they first consented.

Conditions

• Neurogenic Bladder Disorder
• Lower Urinary Tract Disorder
• Urinary Tract Infection (Diagnosis)

Interventions

DIAGNOSTIC_TEST

urine Resazurin Reduction Ratio

The Jiddu platform is a microfluidic and fluorescent-based approach for rapid determination of AST. The Jiddu platform enables analysis of a urine specimen, where an automated microfluidic cartridge filters bacteria from urine, then mixes the bacteria with growth media, fluorescent reagents, and antibiotics on the microfluidic cartridge. The Jiddu platform reports on the abilities of a pre-set panel of five antibiotics to inhibit microbes identified in the sample. Jiddu's fluorescent detection assay uses alamarBlue, a fluorescent dye first employed to detect cell viability in mammalian cell culture. The process leverages the abilities of living cells to oxidize NADH to NAD+ to induce reduction of a non-fluorescent version of alamarBlue (resazurin) to a highly fluorescent variant (resorufin). The rate of conversion is proportional to bacterial concentration and metabolic rate. Thus, a low rate of conversion correlates with antibiotic non-resistance, and a high rate indicates resistance.

OTHER

USQNB

The USQNB-IDC is a validated tool designed for use by patients. It contains four different categories of symptoms which can be related to a UTI and is used to help standardize patient descriptions of symptoms. It is currently used in standard of care as part of the process to diagnose UTI, combined with standard urine testing results. Participants in the presumed non-UTI arm will complete the questionnaire weekly for up to 6 weeks to develop an individualized baseline level of urinary symptoms and outside of those weekly surveys, it will be made available as many times as necessary whenever they develop symptoms. Those qualifying for the presumed UTI arm based on any of their responses will then complete it again at the time of the in-clinic urine collection, and 3, 7, and 10 days afterwards, with the clock starting over if rescue antibiotics are necessary.

Sponsors & Collaborators

• Loyola University Chicago

  collaborator OTHER

• The Craig H. Neilsen Foundation

  collaborator OTHER

• Medstar Health Research Institute

  lead OTHER

Principal Investigators

• Ana Valeria Aguirre Guemez, MD · Medstar Health Research Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2029-07-31

Completion

2029-07-31

FDA Device

Yes

Countries

• United States

Study Locations