Urinary Tract Infections-UTINCT02623179
Conventional and Molecular Diagnostic Method for Patients With Suspected UTI
A study testing culture versus Molecular diagnostics in people with Urinary Tract Infections-UTI, run by Southwest Regional PCR, LLC.
Trial summary
In this protocol, the investigators are examining the use of a novel pathogen testing technology and method of identification of antibiotic susceptibility against the conventional C \& S testing for patients with both complicated and uncomplicated UTIs. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Urinary Tract Infections-UTI
- What is being tested?
- culture versus Molecular diagnostics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2016to 31 Dec 2016
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age greater than or equal to 18 and less than or equal to 89 years.
- The PI suspects the patient has a complicated or uncomplicated UTI that requires urine testing to confirm diagnosis
- Able to provide at least 8 ml urine total (urine for 2 pathology tests).
- Is willing to complete one follow up surveys and send back to FH.
Who cannot join
- • Unable or unwilling to provide written informed consent.
- Unable to read and write English (surveys are not available or validated in any other language than English).
- Currently on any antibiotic for any clinical indication.
About this study
Official title: Conventional and Molecular Diagnostic Method for Patients With Suspected Urinary Tract Infections: Clinical, Economic, and Quality of Life Outcomes
In this protocol, the investigators are examining the use of a novel pathogen testing technology and method of identification of antibiotic susceptibility against the conventional C \& S testing for patients with both complicated and uncomplicated UTIs. The investigators will examine the two modes in terms of objective patient related outcomes, i.e. 1) diagnostic accuracy and degree of detail of final analysis; 2) time to resolution of symptoms; 3) quality of life as defined by particularly symptomology and "bothersomeness" of the symptoms; and 4) overall cost.
- Conditions
- Urinary Tract Infections-UTI
- Being tested
- culture versus Molecular diagnostics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
culture versus Molecular diagnosticsOther
Treatment based on the results of the FH C \& S testing - Odd Numbers on randomization table
| Study group | Role | What they receive |
|---|---|---|
| A-Culture and Sensitivity group | Active comparator | Diagnosis by Culture and Sensitivity group-Treatment based on the results of the FH C \& S testing - Odd Numbers on randomization table Receives: Other: culture versus Molecular diagnostics |
| B-Diagnosis by Molecular Testing | Active comparator | Diagnosis by Molecular Testing-Treatment based on the results of the PathoGenius molecular testing - Even Numbers on randomization table Receives: Other: culture versus Molecular diagnostics |
What is being measured
The primary outcome is the main question the study is designed to answer.
To quantify differences in the relative abundance and presence of microbial lineages as determined by culture and sequencing technologies.
comparison of culture and sensitivity results to the molecular results
Measured: 1 year
Secondary outcomes (4)
Time (as measured in hours) to preliminary and final identification of organism(s) and antibiotic sensitivity(s) results
time from collection of sample to diagnostic result delivery
Measured: 1 year
Time from participant reported start of UTI symptoms to resolution.
collect time of reported UTI from Subject
Measured: 1 year
Participant Quality of Life as measured by a UTI specific severity and bothersome of symptoms survey taken at baseline (at clinic visit) and at set time points post urine testing
collect data from Subject as outlined in the Quality of Life Assessment
Measured: 1 year
Overall cost
collect data on the overall cost of Subject treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study start15 Jan 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infections-UTIStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwest Regional PCR, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael McDonald, MD, Principal investigator, Florida Hospital Celebration Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623179
- Sponsor's protocol ID
- PATUTI
- Status last verified
- Oct 2017
- First submitted
- 1 Dec 2015
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional and Molecular Diagnostic Method for Patients With Suspected Urinary Tract Infections: Clinical, Economic, and Quality of Life Outcomes
- ClinicalTrials.gov ID
- NCT02623179
- Acronym / sponsor ID
- PATUTI
- Conditions
- Urinary Tract Infections-UTI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Southwest Regional PCR, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 7 Dec 2015 (estimated)
- 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, the investigators are examining the use of a novel pathogen testing technology and method of identification of antibiotic susceptibility against the conventional C \& S testing for patients with both complicated and uncomplicated UTIs. The investigators will examine the two modes in terms of objective patient related outcomes, i.e. 1) diagnostic accuracy and degree of detail of final analysis; 2) time to resolution of symptoms; 3) quality of life as defined by particularly symptomology and "bothersomeness" of the symptoms; and 4) overall cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-Culture and Sensitivity group | Active comparator | Other: culture versus Molecular diagnosticsDiagnosis by Culture and Sensitivity group-Treatment based on the results of the FH C \& S testing - Odd Numbers on randomization table |
| B-Diagnosis by Molecular Testing | Active comparator | Other: culture versus Molecular diagnosticsDiagnosis by Molecular Testing-Treatment based on the results of the PathoGenius molecular testing - Even Numbers on randomization table |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Age greater than or equal to 18 and less than or equal to 89 years.
Key exclusion criteria (3 listed)
- • Unable or unwilling to provide written informed consent.
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 |
|---|---|---|
| culture versus Molecular diagnosticsTreatment based on the results of the FH C \& S testing - Odd Numbers on randomization table | Other | A-Culture and Sensitivity group, B-Diagnosis by Molecular Testing |
Primary outcome
To quantify differences in the relative abundance and presence of microbial lineages as determined by culture and sequencing technologies.
Time frame: 1 year
comparison of culture and sensitivity results to the molecular results
4 secondary outcomes
Time (as measured in hours) to preliminary and final identification of organism(s) and antibiotic sensitivity(s) results
Time frame: 1 year
Time from participant reported start of UTI symptoms to resolution.
Time frame: 1 year
Participant Quality of Life as measured by a UTI specific severity and bothersome of symptoms survey taken at baseline (at clinic visit) and at set time points post urine testing
Time frame: 1 year
Overall cost
Time frame: 1 year
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 5 Oct 2017.
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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.
Michael McDonald, MD principal investigator
Florida Hospital Celebration Health
Questions about this trial
What is this clinical trial studying?
A study testing culture versus Molecular diagnostics in people with Urinary Tract Infections-UTI, run by Southwest Regional PCR, LLC.
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 4 inclusion and 3 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 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
To quantify differences in the relative abundance and presence of microbial lineages as determined by culture and sequencing technologies. (time frame: 1 year). 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 5 Oct 2017.