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)

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.

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.

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