An interventional study of Treatment guided by the PCR results and Treatment guided by the C&S results in Urinary Tract Infection Complicated, Urinary Tract Infection (cUTI) and Urinary Tract Infection (Diagnosis), sponsored by Doc Lab Inc. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Doc Lab Inc · Not applicable, Interventional, and Diagnostic
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:
Secondary endpoints included:
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:
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:
803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.
This study's enrollment of 773 is above the median of 131 across 560 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →This is the only study on the registry with Doc Lab Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment guided by the PCR results
Diagnostic Test: Treatment guided by the PCR results
Treatment guided by the C\&S results
Diagnostic Test: Treatment guided by the C&S results
Patients receive treatment prescribed by a blinded clinician, based solely on the PCR diagnostic results
Patients receive treatment prescribed by a blinded investigator (clinician), based solely on the C\&S diagnostic results.
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.
Time frame: at End Of Study (EOS) visit (Day 28)
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)
Time frame: 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.
Time frame: at End Of Study (EOS) visit (Day 28)
Turnaround Time
Comparison of turnaround time between molecular diagnostic procedures and conventional diagnostic
Time frame: 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
Time frame: 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
Time frame: at End Of Study (EOS) visit (Day 28)
| Milestone | PCR Arm | C&S Arm |
|---|---|---|
| Started | 397 | 376 |
| Completed | 193 | 169 |
| Not completed | 204 | 207 |
| Withdrew: Patients with negative microbiological evidence by both diagnostic methods | 54 | 54 |
| Withdrew: Patients with discordant diagnostic results | 107 | 90 |
| Withdrew: Lost to follow-up | 31 | 56 |
| Withdrew: Withdrawal by subject | 12 | 7 |
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.
| Participants | PCR Arm | C&S Arm |
|---|---|---|
| Favorable Clinical Outcomes (FCl) | 170 | 132 |
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)
| Participants | PCR Arm | C&S Arm |
|---|---|---|
| Microbiological Eradication | 120 | 95 |
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.
| score on a scale (1-25) | PCR Arm | C&S Arm |
|---|---|---|
| Treating Investigator Satisfaction Score | 23.95 ± 1.96 | 20.64 ± 4.12 |
Comparison of turnaround time between molecular diagnostic procedures and conventional diagnostic
| hours | PCR Arm | C&S Arm |
|---|---|---|
| Turnaround Time | 49.68 (2.41 to 152.53) | 104.4 (48.21 to 592.53) |
Overall agreeability between the diagnostic results generated by PCR versus C\&S as assessed by discordant analysis
| percentage | PCR Arm |
|---|---|
| Sensitivity % | 88.6 |
| Specificity % | 62.91 |
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
| Participants | PCR Arm : PCR(+), CS(-) | C&S Arm : PCR(-), CS(+) |
|---|---|---|
| Favorable Clinical Outcome of Patients With Discordant Results | 79 | 10 |
Collected over Day 1 (baseline) and Day 28 (end of study, EOS). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PCR Arm | 0/236 (0%) | 0/236 (0%) | 0/236 (0%) |
| C&S Arm | 0/232 (0%) | 0/232 (0%) | 0/232 (0%) |
| Age, Categorical(Participants) | PCR Arm | C&S Arm | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 52 | 49 | 101 |
| >=65 years | 345 | 327 | 672 |
| Sex: Female, Male(Participants) | PCR Arm | C&S Arm | Total |
|---|---|---|---|
| Female | 272 | 263 | 535 |
| Male | 125 | 113 | 238 |
| Race and Ethnicity Not Collected(Participants) | PCR Arm | C&S Arm | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2023 to primary completion in Apr 2024, 8 months.
Results were first posted in Sep 2025, 1 year 4 months after primary completion.
Of 153 interventional studies with no phase under Urinary Tract Infections, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's 8 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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