Urinary Tract InfectionsRapIDMixARNCT03931538
Rapid Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR) Prospective Study
A study testing Guidance 4.0 PCR test and Urine Culture in people with Urinary Tract Infections and Prostatitis, run by Pathnostics at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections, Prostatitis, Interstitial Cystitis
- What is being tested?
- Guidance 4.0 PCR test and Urine Culture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,511 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2018to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- • Patient Informed Consent form completed
- Male and Female Subjects may participate with no predetermined quotas or ratios for gender participation.
- All patients must be ≥60 years old. For patients presenting with a diagnosis of interstitial cystitis, patients may be of any age.
- Patients must be presenting for treatment of acute UTI, complicated UTI, persistent UTI, or recurrent UTI's.
- Including prostatitis, pyelonephritis, and/or interstitial cystitis.
- Data pertaining to the times at which the specimen samples are collected and stabilized needs to be documented.
- Specimen samples obtained need to have a sufficient volume necessary to perform a urine culture and Guidance 4.0.
Who cannot join
- • Do not provide written informed Consent with HIPAA authorization form.
- Taking antibiotics for any reason other than UTI at the time of enrollment
- Patients with chronic (> 10 days) indwelling catheters
- Self-catheterized patients
- Patients with neobladders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urinary Tract Infection: RapID Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR)
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.
Read the detailed description
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.
- Conditions
- Urinary Tract Infections, Prostatitis, Interstitial Cystitis
- Being tested
- Guidance 4.0 PCR test, Urine Culture
- Keywords
- UTI, IC
- Medical subject headings
- Urinary Tract Infections, Prostatitis, Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guidance 4.0 PCR testDiagnostic test
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.
Urine CultureDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Culture Only | Active comparator | Physician receives only culture result Receives: Diagnostic Test: Urine Culture |
| Guidance 4.0 PCR test only | Active comparator | Physician receives Guidance report only Receives: Diagnostic Test: Guidance 4.0 PCR test |
| Culture and Guidance 4.0 PCR test Group | Active comparator | Physician receives both results, gets Culture report immediately before Guidance Receives: Diagnostic Test: Guidance 4.0 PCR test; Diagnostic Test: Urine Culture |
| Guidance 4.0 PCR test and culture group | Active comparator | Physician receives both results, gets Guidance report immediately before culture Receives: Diagnostic Test: Guidance 4.0 PCR test; Diagnostic Test: Urine Culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 Days
Secondary outcomes (2)
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.
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start17 Jul 2018
- Primary completion22 Feb 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 2,511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pathnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Comprehensive Urology-a Division of Michigan Healthcare Professionals
- Responsible party
- Sponsor
- Investigators
- Kirk Wojno, MD, Principal investigator, Comprehensive Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931538
- Sponsor's protocol ID
- Pathnostics RapID MixAR
- Acronym
- RapIDMixAR
- Status last verified
- Aug 2023
- First submitted
- 25 Apr 2019
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Tract Infection: RapID Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR)
- ClinicalTrials.gov ID
- NCT03931538
- Acronym / sponsor ID
- RapIDMixAR / Pathnostics RapID MixAR
- Conditions
- Urinary Tract Infections, Prostatitis, Interstitial Cystitis
- Keywords
- UTI, IC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,511 participants (actual)
- Lead sponsor
- PathnosticsIndustry (pharma, biotech, devices)
- Collaborators
- Comprehensive Urology-a Division of Michigan Healthcare Professionals
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 22 Feb 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Culture Only | Active comparator | Diagnostic Test: Urine CulturePhysician receives only culture result |
| Guidance 4.0 PCR test only | Active comparator | Diagnostic Test: Guidance 4.0 PCR testPhysician receives Guidance report only |
| Culture and Guidance 4.0 PCR test Group | Active comparator | Diagnostic Test: Guidance 4.0 PCR test, Diagnostic Test: Urine CulturePhysician receives both results, gets Culture report immediately before Guidance |
| Guidance 4.0 PCR test and culture group | Active comparator | Diagnostic Test: Guidance 4.0 PCR test, Diagnostic Test: Urine CulturePhysician receives both results, gets Guidance report immediately before culture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Patient Informed Consent form completed
Key exclusion criteria (5 listed)
- • Do not provide written informed Consent with HIPAA authorization form.
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 |
|---|---|---|
| Guidance 4.0 PCR testAll 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. | Diagnostic test | Culture and Guidance 4.0 PCR test Group, Guidance 4.0 PCR test and culture group, Guidance 4.0 PCR test only |
| Urine CultureAll 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. | Diagnostic test | Culture Only, Culture and Guidance 4.0 PCR test Group, Guidance 4.0 PCR test and culture group |
Primary outcome
Establish Safety: composite adverse event rate
Time frame: 7 Days
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.
2 secondary outcomes
Number of Patients with Recurrent and Persistent Infections in Each Arm
Time frame: 7 Days
Time to Symptom Resolution in Each Arm
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
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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.
Kirk Wojno, MD principal investigator
Comprehensive Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guidance 4.0 PCR test and Urine Culture in people with Urinary Tract Infections and Prostatitis, run by Pathnostics at 1 site 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 7 inclusion and 5 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 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Establish Safety: composite adverse event rate (time frame: 7 Days). 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 28 Aug 2023.