Clinical Utility of a PCR Compared to Culture and Sensitivity Testing for the Management of cUTI in Adults.
Public ClinicalTrials.gov record NCT06996301. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Clinical Validity and Utility of PCR Compared to Conventional Culture and Sensitivity Testing for the Management of Complicated Urinary Tract Infections in Adults.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06996301
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 773 participants
Conditions and interventions
Conditions
Interventions
- Treatment guided by the PCR results Diagnostic Test
- Treatment guided by the C&S results Diagnostic Test
Diagnostic Test
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 30, 2023
- Primary completion
- Apr 29, 2024
- Completion
- May 30, 2024
- Last update posted
- Sep 10, 2025
2023 – 2024
United States locations
- U.S. sites
- 6
- U.S. states
- 4
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Silicon Valley Medical Development | San Jose | California | 95124 | — |
| Albany Urology Clinic & Surgery Center | Albany | Georgia | 31707 | — |
| Augusta Urology Associates | Evans | Georgia | 30809 | — |
| Colquitt Regional Medical Center | Moultrie | Georgia | 31768 | — |
| Phoenix Urology of St Joseph | Saint Joseph | Missouri | 64506 | — |
| Norman Urology Associates | Norman | Oklahoma | 73071 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06996301, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 10, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06996301 live on ClinicalTrials.gov.