NCT03931538

Rapid Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR) Prospective Study

Urinary Tract Infection: RapID Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,511 (actual)
• Sponsor: Pathnostics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Guidance 4.0 PCR 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.
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.

Timeline

• Start date: 2018-07-17
• Primary completion: 2019-02-22
• Completion: 2019-10-01
• First posted: 2019-04-30
• Last updated: 2023-08-28

Locations

1 site across 1 country: United States