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.
age≥18 years;
patient-reported diagnosis of neurogenic bladder;
using urethral or suprapubic catheterization for bladder management;
presenting for suspected symptomatic UTI; and
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
Crossover
urine Resazurin Reduction Ratio
Diagnostic testThe 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.
USQNB
Other interventionThe 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.
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.
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.
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).
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Medstar Health Research Institute
Lead sponsor
Loyola University Chicago
Collaborator
The Craig H. Neilsen Foundation
Collaborator
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