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

Pathnostics

Status: Completed

Conditions: Urinary Tract Infections; Prostatitis; Interstitial Cystitis

Treatments: Diagnostic Test: Urine Culture; Diagnostic Test: Guidance 4.0 PCR test

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03931538

Pathnostics RapID MixAR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,511 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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2,511 participants in 4 patient groups

Culture Only

Active Comparator group

Description:

Physician receives only culture result

Treatment:

Diagnostic Test: Urine Culture

Guidance 4.0 PCR test only

Active Comparator group

Description:

Physician receives Guidance report only

Treatment:

Diagnostic Test: Guidance 4.0 PCR test

Culture and Guidance 4.0 PCR test Group

Active Comparator group

Description:

Physician receives both results, gets Culture report immediately before Guidance

Treatment:

Diagnostic Test: Urine Culture

Diagnostic Test: Guidance 4.0 PCR test

Guidance 4.0 PCR test and culture group

Active Comparator group

Description:

Physician receives both results, gets Guidance report immediately before culture

Treatment:

Diagnostic Test: Urine Culture

Diagnostic Test: Guidance 4.0 PCR test