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

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)

Interventions

DIAGNOSTIC_TEST

Treatment guided by the PCR results

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

DIAGNOSTIC_TEST

Treatment guided by the C&S results

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

Sponsors & Collaborators

• Dicentra Inc.

  collaborator INDUSTRY

• Doc Lab Inc

  lead INDUSTRY

Principal Investigators

• Roel Chavez · Doc Lab Inc

• Thomas K Huard, PhD · MED-US Consulting, LLC

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-31

Primary Completion

2024-04-30

Completion

2024-05-31

FDA Device

Yes

Countries

• United States

Study Locations