An interventional study of Guidance 4.0 PCR test and Urine Culture in Urinary Tract Infections, Prostatitis and Interstitial Cystitis, sponsored by Pathnostics. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-28.
Sponsored by Pathnostics · Not applicable, Interventional, and Diagnostic
In this protocol, investigators are examining the ability for a novel multiplex PCR assay with mixed floral antibiotic resistance profiling is safe and increases effective treatment for urinary tract infections in a urology clinic over traditional culture methods alone and decreases retreatment rates in this population.
The novel multiplex real-time PCR assay with mixed floral antibiotic resistance profiling offers a higher degree of sensitivity and specificity than conventional culture methods in the identification of UTI pathogens as determined by the previous prospective comparison study. Additionally, conventional methods are often inadequate in the case of polymicrobial infections. More accurate and timely pathogen identification allows for prompt and more targeted treatment with less reliance on empiric therapy and decreased rates of antibiotic therapy changes and retreatment. This leads to more favorable patient outcomes and decreases the development of resistant organisms.
803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.
This study's enrollment of 2,511 is above the median of 131 across 560 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Pathnostics is the lead sponsor of 7 studies on the registry; none are open to participants now.
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.
Patient form completed
Exclusion Criteria:
Do not provide written with HIPAA authorization form.
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.
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.
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.
Physician receives only culture result
Diagnostic Test: Urine Culture
Physician receives Guidance report only
Diagnostic Test: Guidance 4.0 PCR test
Physician receives both results, gets Culture report immediately before Guidance
Diagnostic Test: Guidance 4.0 PCR test · Diagnostic Test: Urine Culture
Physician receives both results, gets Guidance report immediately before culture
Diagnostic Test: Guidance 4.0 PCR test · Diagnostic Test: Urine Culture
All patients will have a urine culture and Guidance 4.0 PCR test run on their urine, but physicians will receive one or the other, or both depending on the treatment arm.
All patients will have a urine culture and Guidance 4.0 PCR test run on their urine, but physicians will receive one or the other, or both depending on the treatment arm.
Establish Safety: composite adverse event rate
Demonstrate safety of Guidance 4.0 multiplex real-time PCR organism identification with mixed floral antibiotic resistance profiling guided treatment. Safety will be measured with a composite adverse event outcome of urosepsis, pyelonephritis, hospitalization, or the need to attend an urgent care center. The composite adverse event rate in the arm tested with Guidance 4.0 will be shown to be non-inferior to that in the arm tested with traditional urine culture. Superiority will also be tested.
Time frame: 7 Days
Number of Patients with Recurrent and Persistent Infections in Each Arm
Demonstrate non-inferiority and possibly superiority of Guidance 4.0 over traditional urine C\&S with respect to the percentage of recurrent and persistent infections. Persistent is remaining infection at day 7 and recurrent infection is a person that had a second infection within 30 days that was treated with antibiotics.
Time frame: 7 Days
Time to Symptom Resolution in Each Arm
Demonstrate superiority of Guidance 4.0 over traditional urine C\&S with respect to the time to symptom resolution as demonstrated by UTISA tool. Symptom resolution will be defined as an overall rating of no symptoms on the UTISA questionnaire.
Time frame: 7 days
Physician Choice for Decision Making when Provided Both Results
• To determine which test physicians, rely upon when given the results of both traditional urine C\&S vs. Guidance 4.0.
Time frame: 4 Months
Ran from Jul 2018 to primary completion in Feb 2019, 7 months.
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 7 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 Aug 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pathnostics