CompletedNot Applicable

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

United States773 participantsStarted 2023-07-31

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 PK…

What they're measuring

Favorable Clinical Outcomes (FCl)

Timeframe: at End Of Study (EOS) visit (Day 28)

Trial details

NCT IDNCT06996301

SponsorDoc Lab Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-30

Results submitted2025-05-30