Rapid UTI Diagnostics in Lower Urinary Tract Dysfunction Among Catheter Users

August 20, 2026 updated by: Medstar Health Research Institute

Urine Resazurin Reduction Ratio and Phenotypic Antibiotic Susceptibility Testing: A Rapid Diagnostic Tool for Urinary Tract Infection and Lower Urinary Tract Dysfunction Using a Catheter

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants will receive USQNB symptom surveys weekly for 6 weeks, and will have the survey made available to them as many times as they develop urinary symptoms over the course of the 6 month study.

When a participant develops symptoms suggestive of UTI, they will complete the USQNB provided. If they are considered to have a moderate or high likelihood of UTI, they will be assigned to the presumed UTI arm and present to the MNRH clinic for evaluation and treatment of their presumed UTI. At the clinic, the study physician will assess their symptoms and obtain a urine sample from a fresh catheter for dipstick testing. Based on the symptom assessment and dipstick results (performed when confirmed high or moderate profile per USQNB), participants will be classified as either a screen pass (presumed UTI) or a screen fail (no presumed UTI).

Screen pass and screen fail definitions for UTI are based on the following:

Screen pass:

  1. Confirmed High or moderate profile per USQNB within the past 24 hours; and
  2. Dipstick-determined Nitrite (N) & Leukocyte Esterase (LE) are "strong positive" (both N positive and LE moderate or large), "inflammation positive" (N=negative and LE=moderate or large), or "indeterminate" (either LE=small with N positive or negative; or LE=negative or trace and N positive).

Screen fail:

  1. Confirmed High or moderate profile per USQNB within the past 24 hours; and
  2. Dipstick-determined Nitrite (N) & Leukocyte Esterase (LE) are "strong positive" (both N positive and LE moderate or large), "inflammation positive" (N=negative and LE=moderate or large), or "indeterminate" (either LE=small with N positive or negative; or LE=negative or trace and N positive).

The definition of "screen pass" for presumed UTI diagnosis and screen fail are based in the 2010 IDSA Guidelines, the evidence around dipstick in NLUTD (only negative dipstick results are informative), past work on the SCI International UTI Basic Dataset using the USQNB, and international consensus on cUTI guidelines. Additionally, this team has completed work on dipstick assessment that supports the IDSA Guideline on utility of negative dipstick (i.e., N=negative and LE=zero or trace) only.

Individuals who meet the definition of "presumed UTI" will, present to clinic for urine collection, and will be prescribed antibiotics to treat the UTI. After completion of the antibiotics, participants will have completed the study. A total of 100 urine samples will be collected, 50 urine samples from the new catheter (to be used for prescribing) and 50 urine samples from the bag (urine from the same participant) from the IDC population. Each of these urine samples will be divided into three aliquots for analysis as described below.

Day 0 Assessment: Immediately after a patient is identified as a Screen Pass (Presumed UTI on USQNB), urine samples will be collected and divided into 3 aliquots for:

  1. Dipstick, urinalysis and SUC by the Medstar clinical microbiology lab;
  2. Assessment by Jiddu, obtaining uRRR value and pooled phenotypic AST results; and
  3. Biobanking at -80°C for current and future analyses related to UTI diagnostics

Urine Sample Collection For participants who are considered Screen Pass (Presumed UTI on USQNB), two urine samples will be collected. The first sample will be obtained directly from the bladder immediately after replacing the indwelling catheter (IDC). The second sample will be collected from the original drainage bag attached to the IDC present upon presentation to the clinic.

Antibiotic Initiation (Day 0):

Standard of Care (SoC) Empiric Antibiotic Determination: Empiric antibiotic choice will be made by the study clinician using patient-specific previous SUC results, if available. Availability of previous SUC results will be recorded and empiric antibiotic choice will be recorded but not prescribed (recorded as SoC-empiric antibiotic choice, and use of prior SUC results for this decision will also be recorded).

Jiddu-determined pooled phentotypic AST Antibiotic Determination: Jiddu-determined pooled-AST will be determined from the bladder urine sample for IDC (directly from the bladder for IDC). This result will be used for antibiotic determination; this takes approximately 60 minutes. The results ("resistant" or "non-resistant") of each antibiotic pooled-AST will be recorded. If Jiddu-determined pooled-AST results reveal non-resistance to more than one antibiotic, choice of antibiotic to be prescribed will follow these criteria:

  1. If previous SUC and AST results are available, the same or similar class antibiotic will be prescribed (unless it required change to another antibiotic); and
  2. Genitourinary-specific spectrum antibiotic will be used. The clinician will use their best judgement and all available evidence, including the Jiddu-determined pooled-AST results, and prescribe 7 days antibiotic treatment (prescription will be recorded).

Days 1-7 Monitoring During Antibiotic Treatment Period:

Symptoms will be monitored and recorded during the antibiotic treatment period. The USQNB will be readministered on day 3 and 7 during following initiation of treatment through automatic emails from REDCap.

SUC results and SUC-based ASTs will be available between 72-96 hours after study initiation. Results will be recorded. A clinical research assistant (not the study clinician) will record cases where the SoC SUC-based AST characterizes the identified pathogen(s) to be resistant to the Jiddu-determined pooled phenotypic AST treatment.

Need for rescue antibiotics: Study personnel will contact participants between 72-96 hours after the initiation of antibiotic treatment (CRC symptom check) and after SUC-based AST results are available. In cases where symptoms have increased in number, or if the combination of number and type of symptoms has put the patient's risk of UTI level into a greater likelihood category, then Jiddu-determined antibiotics will be discontinued and rescue antibiotics (determined by SUC-based AST) will be prescribed (for an additional 7 days). If rescue antibiotics are used, the 7-day USQNB follow up period will restart.

Day 10 Monitoring During Post-Antibiotic Treatment Period:

Symptoms will be monitored and recorded at the completion of antibiotics on day 10 after antibiotic completion, through automatic emails from REDCap.

Day 0 assessment if Screen fail

If participants fail screening from USQNB questionnaires by not meeting the criteria for UTI per USQNB (high or moderate likelihood UTI profile), he or she will be considered a screen fail. Participants who screen fail will repeat the USQNB on days 3 and 7, or if new symptoms occur at any point during the 7 days following screening (monitoring will be using REDCap). If their symptom profile does not change to meet screen pass criteria during this period, they will continue to be in the study and will continue to be able to complete the USQNB thereafter if they have concerns for a UTI. Individuals who screen fail for UTI can continue to participate in the full 6 month study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • age≥18 years;
  • patient-reported diagnosis of neurogenic bladder;
  • using urethral or suprapubic catheterization for bladder management;
  • presenting for suspected symptomatic UTI; and
  • lives in community or nursing home.

Exclusion Criteria:

  • antibiotic treatment for suspected UTI within past 4 weeks - including as a participant in this study;
  • bladder-instilled antibiotic within the past 2 weeks;
  • psychologic or psychiatric conditions influencing the ability to follow instructions; and
  • participation in another study in which results would be confounded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Presumed UTI

When a participant develops symptoms suggestive of UTI, they will present to clinic and complete the USQNB. If they are still considered to have a moderate or high likelihood of UTI, they will provide urine from a fresh catheter to determine if they are a screen pass:

  1. High or moderate profile per USQNB within the past 24 hours; and
  2. Dipstick-determined Nitrite (N) & Leukocyte Esterase (LE) are "strong positive" (both N positive and LE moderate or large), "inflammation positive" (N=negative and LE=moderate or large), or "indeterminate" (either LE=small with N positive or negative; or LE=negative or trace and N positive).

Individuals who meet the definition of screen pass will provide a second urine sample from the bag and will be prescribed antibiotics to treat the UTI based on best clinical judgement using all available evidence, including the results provided by the experimental diagnostic device. After completion of the antibiotics, participants will have completed the study.
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 Names:
  • Jiddu
  • uRRR
  • phenotypic pooled AST
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.
Other Names:
  • urinary symptom questionnaire
Active Comparator: Presumed no UTI

Participants will be classified as "screen fail" if they do not have at least one new-onset symptom on the USQNB of type A and at least one new on-set symptom of type B (B1 or B2) within the last 24 hours). These participants will then be consented and he or she will be considered a screen fail. Participants who screen fail will repeat the USQNB on days 3 and 7, or if new symptoms occur at any point during the 7 days following screening (using REDCap for follow-up). If their symptom profile does not change to meet screen pass criteria during this period, they will continue to be in the study and will only complete the USQNB thereafter if they have new concerns for a UTI. Individuals who screen fail for UTI can continue to participate in the full 6-month study.

If during that 6 month period, an individual in the Presumed no UTI arm develops symptoms that would qualify them for the Presumed UTI arm, they will then "crossover" and begin that arm of the study.
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.
Other Names:
  • urinary symptom questionnaire

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Urinary Symptoms
Time Frame: 10 to 13 days
Urinary symptoms will be measured during the course of antibiotic treatment via the USQNB. The change in presence or absence of these symptoms will be used to evaluate the effectiveness of the prescribed antibiotic in treating the UTI.
10 to 13 days
Sensitivity and Specificity of Jiddu UTI Identification
Time Frame: 1 to 4 hours
To estimate the sensitivity and specificity of Jiddu's identification of UTI using its NADH to NAD+ conversion value cutoff with the combination of USQNB symptomatology and the non-negative dipstick results (nitrite and leukocyte esterase reflect either "strong positive", "inflammation positive" or "indeterminate"), we will use Cohen's kappa, estimating agreement corrected for chance, to compute agreement of the uRRR value UTI yes/no determination against the criteria for presumed UTI. We will carry out these kappa calculations first separately by bladder management method and then with the full sample together. Standard errors of the kappa estimates and a 95% confidence interval are provided in R.
1 to 4 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Estimated Jiddu Antibiotic Recommendation Contribution
Time Frame: 1 to 4 hours
To estimate the contribution of the Jiddu platform pooled AST to clinical judgment about antibiotic selection, of the 100 screen passes with "presumed UTI" who undergo pooled phenotypic AST and receive antibiotics, we will determine the absolute number in which the Jiddu pooled-AST result changes the choice of antibiotic the clinician made prior to obtaining the Jiddu uRRR results. We will quantify the cases where the clinician made a choice that is confirmed by the Jiddu pooled phenotypic AST result (%) as a secondary measure of accuracy (i.e., treat the clinician's choice as "the gold standard" and count the cases where Jiddu-based AST includes the drug that was chosen).
1 to 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medstar Health Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Loyola University Chicago
The Craig H. Neilsen Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ana Valeria Aguirre Guemez, MD, Medstar Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00008628
  • 1512491 (Other Grant/Funding Number: Craig H. Neilsen Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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