Status:
COMPLETED
Clinical Utility of a PCR Compared to Culture and Sensitivity Testing for the Management of cUTI in Adults.
Lead Sponsor:
Doc Lab Inc
Collaborating Sponsors:
Dicentra Inc.
Conditions:
Urinary Tract Infection Complicated
Urinary Tract Infection (cUTI)
Eligibility:
All Genders
18+ years
Phase:
NA
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-cent...
Detailed Description
Study Overview: Complicated urinary tract infections (cUTIs) remain a significant clinical challenge, often prompting empiric antibiotic use that may result in inappropriate therapy, antimicrobial ov...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
773 Patients enrolled
Trial Details
Trial ID
NCT06996301
Start Date
July 31 2023
End Date
May 31 2024
Last Update
September 11 2025
Active Locations (6)
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1
Silicon Valley Medical Development
San Jose, California, United States, 95124
2
Albany Urology Clinic & Surgery Center
Albany, Georgia, United States, 31707
3
Augusta Urology Associates
Evans, Georgia, United States, 30809
4
Colquitt Regional Medical Center
Moultrie, Georgia, United States, 31768