Neurogenic Bladder DisorderNCT07784829
Rapid UTI Diagnostics in Lower Urinary Tract Dysfunction Among Catheter Users
A study testing urine Resazurin Reduction Ratio and USQNB in people with Neurogenic Bladder Disorder and Lower Urinary Tract Disorder, run by Medstar Health Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurogenic Bladder Disorder, Lower Urinary Tract Disorder, Urinary Tract Infection (Diagnosis)
- What is being tested?
- urine Resazurin Reduction Ratio and USQNB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010
Madison Hughes, MS, 202-877-1000, madison.r.hughes@medstar.net
Inger Ljungberg, MPH, 202-877-1964, inger.h.ljungberg@medstar.net
About this study
Official title: 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.
Read the 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:
- Confirmed High or moderate profile per USQNB within the past 24 hours; and
- 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:
- Confirmed High or moderate profile per USQNB within the past 24 hours; and
- 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:
- Dipstick, urinalysis and SUC by the Medstar clinical microbiology lab;
- Assessment by Jiddu, obtaining uRRR value and pooled phenotypic AST results; and
- 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:
- 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
- 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.
- Conditions
- Neurogenic Bladder Disorder, Lower Urinary Tract Disorder, Urinary Tract Infection (Diagnosis)
- Being tested
- urine Resazurin Reduction Ratio, USQNB
- Keywords
- UTI, neurogenic bladder, diagnosis, NLUTD, resazurin
- Medical subject headings
- Urinary Bladder, Neurogenic, Urinary Tract Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine Resazurin Reduction RatioDiagnostic test
Also called Jiddu, uRRR, phenotypic pooled AST
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.
USQNBOther
Also called urinary symptom questionnaire
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.
| Study group | Role | What they receive |
|---|---|---|
| Presumed UTI | Experimental | 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. Receives: Diagnostic Test: urine Resazurin Reduction Ratio; Other: USQNB |
| Presumed no UTI | Active comparator | 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. Receives: Other: USQNB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Symptoms
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.
Measured: 10 to 13 days
Sensitivity and Specificity of Jiddu UTI Identification
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"), the investigator 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. The investigator 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.
Measured: 1 to 4 hours
Secondary outcomes (1)
Estimated Jiddu Antibiotic Recommendation Contribution
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, the investigator 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. The investigator 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).
Measured: 1 to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Bladder DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Loyola University Chicago, The Craig H. Neilsen Foundation
- Responsible party
- Sponsor
- Investigators
- Ana Valeria Aguirre Guemez, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784829
- Sponsor's protocol ID
- STUDY00008628
- Other IDs
- 1512491
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07784829
- Acronym / sponsor ID
- STUDY00008628
- Conditions
- Neurogenic Bladder Disorder, Lower Urinary Tract Disorder, Urinary Tract Infection (Diagnosis)
- Keywords
- UTI, neurogenic bladder, diagnosis, NLUTD, resazurin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Loyola University Chicago, The Craig H. Neilsen Foundation
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Confirmed High or moderate profile per USQNB within the past 24 hours; and
- 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:
- Confirmed High or moderate profile per USQNB within the past 24 hours; and
- 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:
- Dipstick, urinalysis and SUC by the Medstar clinical microbiology lab;
- Assessment by Jiddu, obtaining uRRR value and pooled phenotypic AST results; and
- 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:
- 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
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Presumed UTI | Experimental | Diagnostic Test: urine Resazurin Reduction Ratio, Other: USQNBWhen 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. |
| Presumed no UTI | Active comparator | Other: USQNBParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urine Resazurin Reduction RatioAlso: Jiddu, uRRR, phenotypic pooled ASTThe 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. | Diagnostic test | Presumed UTI |
| USQNBAlso: urinary symptom questionnaireThe 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 | Presumed UTI, Presumed no UTI |
Primary outcome
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.
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"), the investigator 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. The investigator 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 secondary outcome
Estimated Jiddu Antibiotic Recommendation Contribution
Time frame: 1 to 4 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Shares eligibility information and recruitment contact informationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ana Valeria Aguirre Guemez, MD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urine Resazurin Reduction Ratio and USQNB in people with Neurogenic Bladder Disorder and Lower Urinary Tract Disorder, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madison Hughes, MS (202-877-1000, madison.r.hughes@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Symptoms (time frame: 10 to 13 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.