Urinary Tract Infection ComplicatedPCRNCT06996301
Clinical Utility of a PCR Compared to Culture and Sensitivity Testing for the Management of cUTI in Adults.
A study testing Treatment guided by the PCR results and Treatment guided by the C&S results in people with Urinary Tract Infection Complicated and Urinary Tract Infection (cUTI), run by Doc Lab Inc at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection Complicated, Urinary Tract Infection (cUTI), Urinary Tract Infection (Diagnosis)
- What is being tested?
- Treatment guided by the PCR results and Treatment guided by the C&S results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 773 participants
- Where
- 6 sitesUnited States
- Study dates
- 31 Jul 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Albany Urology Clinic & Surgery Center
Albany, Georgia, 31707
Augusta Urology Associates
Evans, Georgia, 30809
Colquitt Regional Medical Center
Moultrie, Georgia, 31768
Norman Urology Associates
Norman, Oklahoma, 73071
Phoenix Urology of St Joseph
Saint Joseph, Missouri, 64506
Silicon Valley Medical Development
San Jose, California, 95124
About this study
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.
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.
Read more
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.
Read the 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 overuse, and treatment failure. This study aimed to evaluate the clinical utility of molecular diagnostics (PCR) versus Conventional culture and sensitivity (C\&S) methods in managing cUTIs, with the goal of identifying more effective patient management strategies.
This was a randomized, parallel-group, investigator-blinded, multi-center clinical trial conducted across six sites in the United States. Adults meeting all inclusion and no exclusion criteria who provided informed consent were randomized 1:1 into two arms: PCR-guided therapy and C\&S-guided therapy. Each participant provided a urine sample before randomization, which was tested using both PCR and C\&S. However, treating investigators remained blinded to the comparator test results throughout the study to ensure unbiased clinical decision-making.
Study Protocol:
Urine specimens were collected using a clean-catch midstream method at two time points: Day 1 (baseline) and Day 28 (end of study, EOS). Samples were refrigerated at 2-8°C and processed at a central lab. All specimens were split for parallel testing using:
- PCR (DocLab UTM 2.0): A qualitative panel targeting 28 uropathogen species and 16 antimicrobial resistance gene classes via QuantStudio 7/12 and KingFisher platforms.
- Conventional C\&S: Quantitative bacterial culture and sensitivity testing to identify uropathogens and assess resistance profiles, with a detection threshold of ≥10⁵ CFU/mL.
Blinding and Treatment Allocation:
Participants were treated based exclusively on the test result assigned by randomization (PCR or C\&S). Comparator test results were withheld from clinicians until after the study concluded.
The primary endpoint was 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.
The secondary endpoint included several assessments:
- Number (and percentage) of subjects with microbiological eradication at the EOS, defined as achieving a quantitative urine culture at the EOS indicating a reduction of all uro-pathogens present at baseline to <10^5 colony forming unit per milliliter (CFU/mL) and the absence of baseline pathogens detected by EOS urine PCR (Cq > 33);
- Subjective measurement of treating investigator satisfaction score through a questionnaire (5 questions) at EOS, evaluated factors such as (1) result availability/timeliness, (2) clarity of result interpretation, (3) clinical decision-making utility, (4) overall test satisfaction, and (5) perceived impact on patient outcomes versus comparator.
- Comparison of turnaround time between molecular diagnostic procedures and conventional diagnostic
- Overall agreeability between the diagnostic results generated by PCR versus C\&S as assessed by discordant analysis
- Assessment of the favorable clinical outcome of patients with discordant results [PCR(+), CS(-) and PCR(-), CS(+)]
- Conditions
- Urinary Tract Infection Complicated, Urinary Tract Infection (cUTI), Urinary Tract Infection (Diagnosis)
- Being tested
- Treatment guided by the PCR results, Treatment guided by the C&S results
- 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
- Medical subject headings
- Urinary Tract Infections, Disease, Pathologic Complete Response, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment guided by the PCR resultsDiagnostic test
Patients receive treatment prescribed by a blinded clinician, based solely on the PCR diagnostic results
Treatment guided by the C&S resultsDiagnostic test
Patients receive treatment prescribed by a blinded investigator (clinician), based solely on the C\&S diagnostic results.
| Study group | Role | What they receive |
|---|---|---|
| PCR Arm | Other | Treatment guided by the PCR results Receives: Diagnostic Test: Treatment guided by the PCR results |
| C&S Arm | Other | Treatment guided by the C\&S results Receives: Diagnostic Test: Treatment guided by the C&S results |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at End Of Study (EOS) visit (Day 28)
Secondary outcomes (5)
Microbiological Eradication
Number (and percentage) of subjects with microbiological eradication at the EOS, defined as achieving a quantitative urine culture at the EOS indicating a reduction of all uro-pathogens present at baseline to <10^5 colony forming unit per milliliter (CFU/mL) and the absence of baseline pathogens detected by EOS urine PCR (Cq > 33)
Measured: at End Of Study (EOS) visit (Day 28)
Treating Investigator Satisfaction Score
Subjective measurement of treating investigator satisfaction score through a questionnaire (5 questions) at EOS, evaluated factors such as (1) result availability/timeliness, (2) clarity of result interpretation, (3) clinical decision-making utility, (4) overall test satisfaction, and (5) perceived impact on patient outcomes versus comparator.
Scale information Score Interpretation: Each item scored 1-5; higher scores reflect greater diagnostic and therapeutic value.
Total score meaning:
- ≥20: Good clinical utility.
- 10-19: Moderate utility.
- 1-9: Poor utility.
Measured: at End Of Study (EOS) visit (Day 28)
Turnaround Time
Comparison of turnaround time between molecular diagnostic procedures and conventional diagnostic
Measured: at End Of Study (EOS) visit (Day 28)
Overall Agreeability
Overall agreeability between the diagnostic results generated by PCR versus C\&S as assessed by discordant analysis
Measured: at End Of Study (EOS) visit (Day 28)
Favorable Clinical Outcome of Patients With Discordant Results
Assessment of the favorable clinical outcome of patients with discordant results [PCR(+), CS(-) and PCR(-), CS(+)] Patients with discordant results [PCR(+), CS(-) and PCR(-), CS(+)] were excluded from the primary endpoint analysis and their outcome is presented here as a secondary analysis
Measured: at End Of Study (EOS) visit (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start31 Jul 2023
- Primary completion30 Apr 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Tract Infection ComplicatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 773 participants (actual)
Sponsor and investigators
- Lead sponsor
- Doc Lab Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dicentra Inc.
- Responsible party
- Sponsor
- Investigators
- Roel Chavez, Study chair, Doc Lab IncThomas K Huard, PhD, Principal investigator, MED-US Consulting, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996301
- Sponsor's protocol ID
- 22-UPHUV-01
- Acronym
- PCR
- Status last verified
- Jul 2025
- First submitted
- 21 May 2025
- Last updated
- 11 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06996301
- Acronym / sponsor ID
- PCR / 22-UPHUV-01
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 773 participants (actual)
- Lead sponsor
- Doc Lab IncIndustry (pharma, biotech, devices)
- Collaborators
- Dicentra Inc.
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 30 May 2025 (actual)
- Results
- Posted 11 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 overuse, and treatment failure. This study aimed to evaluate the clinical utility of molecular diagnostics (PCR) versus Conventional culture and sensitivity (C\&S) methods in managing cUTIs, with the goal of identifying more effective patient management strategies.
This was a randomized, parallel-group, investigator-blinded, multi-center clinical trial conducted across six sites in the United States. Adults meeting all inclusion and no exclusion criteria who provided informed consent were randomized 1:1 into two arms: PCR-guided therapy and C\&S-guided therapy. Each participant provided a urine sample before randomization, which was tested using both PCR and C\&S. However, treating investigators remained blinded to the comparator test results throughout the study to ensure unbiased clinical decision-making.
Study Protocol:
Urine specimens were collected using a clean-catch midstream method at two time points: Day 1 (baseline) and Day 28 (end of study, EOS). Samples were refrigerated at 2-8°C and processed at a central lab. All specimens were split for parallel testing using:
- PCR (DocLab UTM 2.0): A qualitative panel targeting 28 uropathogen species and 16 antimicrobial resistance gene classes via QuantStudio 7/12 and KingFisher platforms.
- Conventional C\&S: Quantitative bacterial culture and sensitivity testing to identify uropathogens and assess resistance profiles, with a detection threshold of ≥10⁵ CFU/mL.
Blinding and Treatment Allocation:
Participants were treated based exclusively on the test result assigned by randomization (PCR or C\&S). Comparator test results were withheld from clinicians until after the study concluded.
The primary endpoint was 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.
The secondary endpoint included several assessments:
- Number (and percentage) of subjects with microbiological eradication at the EOS, defined as achieving a quantitative urine culture at the EOS indicating a reduction of all uro-pathogens present at baseline to <10^5 colony forming unit per milliliter (CFU/mL) and the absence of baseline pathogens detected by EOS urine PCR (Cq > 33);
- Subjective measurement of treating investigator satisfaction score through a questionnaire (5 questions) at EOS, evaluated factors such as (1) result availability/timeliness, (2) clarity of result interpretation, (3) clinical decision-making utility, (4) overall test satisfaction, and (5) perceived impact on patient outcomes versus comparator.
- Comparison of turnaround time between molecular diagnostic procedures and conventional diagnostic
- Overall agreeability between the diagnostic results generated by PCR versus C\&S as assessed by discordant analysis
- Assessment of the favorable clinical outcome of patients with discordant results [PCR(+), CS(-) and PCR(-), CS(+)]
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCR Arm | Other | Diagnostic Test: Treatment guided by the PCR resultsTreatment guided by the PCR results |
| C&S Arm | Other | Diagnostic Test: Treatment guided by the C&S resultsTreatment guided by the C\&S results |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment guided by the PCR resultsPatients receive treatment prescribed by a blinded clinician, based solely on the PCR diagnostic results | Diagnostic test | PCR Arm |
| Treatment guided by the C&S resultsPatients receive treatment prescribed by a blinded investigator (clinician), based solely on the C\&S diagnostic results. | Diagnostic test | C&S Arm |
Primary outcome
Favorable Clinical Outcomes (FCl)
Time frame: at End Of Study (EOS) visit (Day 28)
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.
5 secondary outcomes
Microbiological Eradication
Time frame: at End Of Study (EOS) visit (Day 28)
Treating Investigator Satisfaction Score
Time frame: at End Of Study (EOS) visit (Day 28)
Turnaround Time
Time frame: at End Of Study (EOS) visit (Day 28)
Overall Agreeability
Time frame: at End Of Study (EOS) visit (Day 28)
Favorable Clinical Outcome of Patients With Discordant Results
Time frame: at End Of Study (EOS) visit (Day 28)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roel Chavez study chair
Doc Lab Inc
Thomas K Huard, PhD principal investigator
MED-US Consulting, LLC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment guided by the PCR results and Treatment guided by the C&S results in people with Urinary Tract Infection Complicated and Urinary Tract Infection (cUTI), run by Doc Lab Inc at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favorable Clinical Outcomes (FCl) (time frame: at End Of Study (EOS) visit (Day 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.