Clinical Utility of a PCR Compared to Culture and Sensitivity Testing for the Management of cUTI in Adults.

Completed · Not applicable

Conditions studied: Urinary Tract Infection Complicated, Urinary Tract Infection (cUTI), Urinary Tract Infection (Diagnosis)

In brief

Complicated urinary tract infections (cUTIs) often lead to the overuse of empiric antibiotics, risking inappropriate treatment and contributing to antimicrobial resistance. This randomized, multi-center, investigator-blinded clinical trial is the first global head-to-head comparison of molecular diagnostic testing (Polymerase Chain Reaction : PCR) versus conventional culture and sensitivity (C\&S) for managing cUTIs in adults. Conducted across six U.S. clinical sites, the study aimed to evaluate the clinical utility of PCR-guided treatment relative to C\&S-guided care. Eligible adult patients were randomized 1:1 into two diagnostic arms-PCR or C\&S-after providing informed consent. Urine samples were collected before randomization, tested by both methods, but clinicians remained blinded to the comparator results to avoid bias. Treatment decisions were based only on the assigned test results. Urine was collected at baseline (Day 1) and at end-of-study (Day 28). Samples were processed centrally: the PCR method (DocLab UTM 2.0) detected 28 uropathogens and 16 antibiotic resistance gene classes; C\&S testing quantified bacterial loads and assessed antimicrobial susceptibility using standard thresholds (≥10⁵ CFU/mL). The primary endpoint was the number of patients in each arm achieving a Favorable Clinical Outcome (FCl) at Day 28, defined as either: * Clinical Cure (complete symptom resolution requiring no further antibiotics), or * Clinical Improvement (partial symptom resolution without new symptoms or IV antibiotics). Secondary endpoints included: * Microbiological eradication at EOS (via C\&S and PCR). * Clinician satisfaction with diagnostic usefulness and result clarity. * Turnaround time comparison between PCR and C\&S. * Concordance analysis of test results between PCR and C\&S. * FCl rates in discordant cases, where PCR and C\&S results disagreed.

Key facts

Study ID: NCT06996301
Run by: Doc Lab Inc
People needed: 773
Starts: 2023-07-31
Expected to finish: 2024-05-31
Last updated by the study team: 2025-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

I1. At least 18 years of age at the time of consent
I2. Presenting at least two of the following new, persistent or worsening cUTI signs and symptoms at screening visit: a) fever (temperature >38 degrees Celsius or >100.4 degrees Fahrenheit), hypothermia (temperature <35.5 degrees Celsius or <95.9 degrees Fahrenheit), rigors, or chills b) dysuria, urinary frequency, urgency, or hematuria c) suprapubic pain or pelvic pain d) costovertebral angle (CVA) tenderness e) nausea or vomiting f) radiographic evidence of pyelonephritis g) leukocytosis
I3. Urine specimen with evidence of pyuria a) dipstick analysis positive for nitrite and/or leukocyte esterase, or; b) ≥10 white blood cells (WBCs) per cubic millimeter [mm3], or; c) ≥10 WBCs per high power field (hpf), or; d) clinically suspected pyuria (e.g. change in urine color, sediment in urine, or foul-smelling urine)
I4. Having cUTI that requires microbiological diagnosis and treatment as suspected by the Investigator
I5. Presenting active UTI that failed to resolve on first-line therapy or identified as a high-risk* patient population; *High-risk patient population include those who are elderly (≥65years), male, pregnant, having recurrent UTI (≥3/year), with underlying co-morbidities (e.g. diabetes, immunosuppression, or CKD), or with known functional and anatomical abnormalities of the urinary tract (e.g. stones, stents, recent instrumentation, indwelling catheters, neurogenic bladder, or PKD)
I6. Able to provide at least 8 mL urine at visit 1 and 3
I7. Willing to abstain from sexual intercourse or use condoms during any sexual contact until the End-of-Study (EOS) visit is complete
I8. Willing to comply with protocol requirements, including availability for follow-up for the duration of the study

You may not qualify if…

E1. Unable or unwilling to provide written informed consent
E2. Unable to read and write in English (surveys are not available or validated in any other language than English)
E3. Currently participating in or has participated in an interventional clinical trial with an investigational product or device within 30 days prior to the Screening Visit
E4. Currently on or chronic use of any antibiotics for any clinical indication, other than UTI
E5. Receipt of any dose of a potentially therapeutic oral or systemic antibiotics for the treatment of UTI within 48 hours before the study baseline urine is obtained
E6.Pregnant women with known fetal congenital anomaly (e.g., genetic abnormality or major congenital malformation) based on antenatal ultrasound
E7. Any rapidly progressing disease or immediately life-threatening illness, including acute hepatic failure, or respiratory failure
E8. Medical condition or other factor that in the judgment of the investigator might affect ability to comply with procedures

Where it is running

Silicon Valley Medical Development — San Jose, California, United States
Albany Urology Clinic & Surgery Center — Albany, Georgia, United States
Augusta Urology Associates — Evans, Georgia, United States
Colquitt Regional Medical Center — Moultrie, Georgia, United States
Phoenix Urology of St Joseph — Saint Joseph, Missouri, United States
Norman Urology Associates — Norman, Oklahoma, United States

Full record on ClinicalTrials.gov

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