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Clinical Utility of a PCR Compared to Culture and Sensitivity Testing for the Management of cUTI in Adults.
NCT06996301 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DIAGNOSTIC_TEST Treatment guided by the PCR results
- DIAGNOSTIC_TEST Treatment guided by the C&S results
Study Locations (6)
Georgia
- Albany Urology Clinic & Surgery Center — Albany
- Augusta Urology Associates — Evans
- Colquitt Regional Medical Center — Moultrie
California
- Silicon Valley Medical Development — San Jose
Missouri
- Phoenix Urology of St Joseph — Saint Joseph
Oklahoma
- Norman Urology Associates — Norman
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 773 participants |
| Start Date | 2023-07-31 |
| Est. Completion | 2024-05-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06996301
The ClinicalTrials.gov registry entry for NCT06996301 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 773 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Doc Lab, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Urinary Tract Infection (Diagnosis) appearing as the primary indexed condition, and to 2 interventions — of which Treatment guided by the PCR results is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06996301 reports 6 study locations spanning 4 distinct geographic areas — top geographies include Georgia, California, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06996301 about?
NCT06996301 is a clinical study titled "Clinical Utility of a PCR Compared to Culture and Sensitivity Testing for the Management of cUTI in Adults.". 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 dia...
What is the current status of trial NCT06996301?
This trial is currently completed. It is a NA study. The enrollment target is 773 participants. The study started on 2023-07-31. Estimated completion is 2024-05-31.
What conditions does trial NCT06996301 study?
This clinical trial studies the following conditions: Urinary Tract Infection (Diagnosis), Urinary Tract Infection Complicated, Urinary Tract Infection (cUTI). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06996301?
The interventions under investigation include: Treatment guided by the PCR results (DIAGNOSTIC_TEST), Treatment guided by the C&S results (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06996301?
This trial is sponsored by Doc Lab, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06996301 being conducted?
This trial has 6 study locations across California, Georgia, Missouri, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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