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

NCT06996301 | Completed Results FDA Device

• 1 other identifier: 22-UPHUV-01
• Study Type: interventional
• Target: 773
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Urinary Tract Infection Complicated; Urinary Tract Infection (cUTI); Urinary Tract Infection (Diagnosis)

Keywords

Complicated urinary tract infection (cUTI); Polymerase Chain Reaction (PCR) diagnostic; Urine culture and sensitivity (C&S) testing; Favorable Clinical Outcomes (FCl); Turnaround Time; Randomized Controlled Trial (RCT); Treatment Outcome

Outcome Measures

Primary Outcomes (1)

• Favorable Clinical Outcomes (FCl)

  The number (and percentage) of subjects in each study arm with favorable clinical outcomes (FCl) at the EOS visit. The FCl was defined as a patient's clinical response, assessed by the treating investigator, indicating either clinical improvement or cure. Clinical improvement was defined as the resolution of at least one symptom of cUTI present at baseline, absence of new cUTI symptoms, and/or avoidance of parenteral antibiotic therapy following randomization. Clinical cure was defined as the complete resolution of all acute signs and symptoms of cUTI present at baseline, to the extent that no further antimicrobial therapy (either IV or oral) was required for the treatment of the cUTI.

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

Secondary Outcomes (5)

• Microbiological Eradication

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

• Treating Investigator Satisfaction Score

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

• Turnaround Time

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

• Overall Agreeability

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

• Favorable Clinical Outcome of Patients With Discordant Results

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

Study Arms (2)

PCR Arm

OTHER

Treatment guided by the PCR results

Diagnostic Test: Treatment guided by the PCR results

C&S Arm

OTHER

Treatment guided by the C\&S results

Diagnostic Test: Treatment guided by the C&S results

Interventions

Treatment guided by the PCR results DIAGNOSTIC_TEST

Patients receive treatment prescribed by a blinded clinician, based solely on the PCR diagnostic results

PCR Arm

Treatment guided by the C&S results DIAGNOSTIC_TEST

Patients receive treatment prescribed by a blinded investigator (clinician), based solely on the C\&S diagnostic results.

C&S Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Doc Lab Inc: lead
• Dicentra Inc.: collaborator

Study Sites (6)

Silicon Valley Medical Development

San Jose, California, 95124, United States

Location

Albany Urology Clinic & Surgery Center

Albany, Georgia, 31707, United States

Location

Augusta Urology Associates

Evans, Georgia, 30809, United States

Location

Colquitt Regional Medical Center

Moultrie, Georgia, 31768, United States

Location

Phoenix Urology of St Joseph

Saint Joseph, Missouri, 64506, United States

Location

Norman Urology Associates

Norman, Oklahoma, 73071, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections; Disease; Pathologic Complete Response; Hypersensitivity

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Progression; Disease Attributes; Immune System Diseases

Results Point of Contact

• Title: Roel Chavez
• Organization: Doc Lab Inc

roel@doclabinc.com

971 570-4008

Study Officials

• Roel Chavez

  Doc Lab Inc

  STUDY CHAIR

• Thomas K Huard, PhD

  MED-US Consulting, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: July 31, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 31, 2024
• Last Updated: September 11, 2025
• Results First Posted: September 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)