Rapid Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR) Prospective Study
United States2,511 participantsStarted 2018-07-17
Plain-language 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 population.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* • 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.
Exclusion Criteria:
* • 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.