Conventional and Molecular Diagnostic Method for Patients With Suspected UTI

Southwest Regional PCR, LLC

Status: Completed

Conditions: Urinary Tract Infections-UTI

Treatments: Other: culture versus Molecular diagnostics

Study type: Interventional

Funder types: Industry

Identifiers

NCT02623179

PATUTI

Details and patient eligibility

About

In this protocol, the investigators are examining the use of a novel pathogen testing technology and method of identification of antibiotic susceptibility against the conventional C & S testing for patients with both complicated and uncomplicated UTIs. The investigators will examine the two modes in terms of objective patient related outcomes, i.e. 1) diagnostic accuracy and degree of detail of final analysis; 2) time to resolution of symptoms; 3) quality of life as defined by particularly symptomology and "bothersomeness" of the symptoms; and 4) overall cost.

Enrollment: 50 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Age greater than or equal to 18 and less than or equal to 89 years.

  • The PI suspects the patient has a complicated or uncomplicated UTI that requires urine testing to confirm diagnosis
  • Able to provide at least 8 ml urine total (urine for 2 pathology tests).
  • Is willing to complete one follow up surveys and send back to FH.

Exclusion criteria

• • Unable or unwilling to provide written informed consent.

  • Unable to read and write English (surveys are not available or validated in any other language than English).
  • Currently on any antibiotic for any clinical indication.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

A-Culture and Sensitivity group

Active Comparator group

Description:

Diagnosis by Culture and Sensitivity group-Treatment based on the results of the FH C \& S testing - Odd Numbers on randomization table

Treatment:

Other: culture versus Molecular diagnostics

B-Diagnosis by Molecular Testing

Active Comparator group

Description:

Diagnosis by Molecular Testing-Treatment based on the results of the PathoGenius molecular testing - Even Numbers on randomization table

Treatment:

Other: culture versus Molecular diagnostics