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NCT03931538 · ClinicalTrials.gov registry record · NA
Rapid Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR) Prospective Study
A NA study of Urinary Tract Infections and Interstitial Cystitis, sponsored by Pathnostics.
- Completed
- Registry status
- NA
- Development phase
- 2,511
- Enrollment target
- 1
- Study location
NCT03931538: Completed NA study of Urinary Tract Infections and Interstitial Cystitis, sponsored by Pathnostics.
NCT03931538 is a NA study of Urinary Tract Infections and Interstitial Cystitis that has completed, run by Pathnostics. The registered enrollment target is 2,511 participants, above the 384-participant average among 34 other Urinary Tract Infections trials with a reported enrollment target (554% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03931538, a NA study of Urinary Tract Infections and Interstitial Cystitis, has completed, sponsored by Pathnostics.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,511 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Urine Culture
- DIAGNOSTIC_TEST Guidance 4.0 PCR test
Study Locations (1)
Michigan
- Comprehensive Urology - Royal Oak
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,511 participants |
| Start Date | 2018-07-17 |
| Est. Completion | 2019-10-01 |
| Phase | NA |
What the finished NCT03931538 record still lists
NCT03931538 is an interventional study that assigns participants to a tested intervention. Its 2,511 participants enrollment target places it among the larger protocols in the corpus, above the 384-participant average among 34 other Urinary Tract Infections trials with a reported enrollment target (554% higher).
The record links to 3 conditions, with Urinary Tract Infections appearing as the primary indexed condition, and to 2 interventions - of which Urine Culture is the first listed.
NCT03931538 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT03931538 about?
NCT03931538 is a clinical study titled "Rapid Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR) Prospective Study". 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 rate...
What is the current status of trial NCT03931538?
This trial is currently completed. It is a NA study. The enrollment target is 2,511 participants. The study started on 2018-07-17. Estimated completion is 2019-10-01.
What conditions does trial NCT03931538 study?
This clinical trial studies the following conditions: Urinary Tract Infections, Interstitial Cystitis, Prostatitis.
What interventions are being tested in trial NCT03931538?
The interventions under investigation include: Urine Culture (DIAGNOSTIC_TEST), Guidance 4.0 PCR test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03931538?
This trial is sponsored by Pathnostics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03931538 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Urinary Tract Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03931538's enrollment target sits among peer trials
2,511 2nd of 34 the highest of 34 other Urinary Tract Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urinary Tract Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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