Conventional and Molecular Diagnostic Method for Patients With Suspected UTI

NCT02623179 | Completed

• 1 other identifier: PATUTI
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Urinary Tract Infections-UTI

Outcome Measures

Primary Outcomes (1)

• To quantify differences in the relative abundance and presence of microbial lineages as determined by culture and sequencing technologies.

  comparison of culture and sensitivity results to the molecular results

  1 year

Secondary Outcomes (4)

• Time (as measured in hours) to preliminary and final identification of organism(s) and antibiotic sensitivity(s) results

  1 year

• Time from participant reported start of UTI symptoms to resolution.

  1 year

• Participant Quality of Life as measured by a UTI specific severity and bothersome of symptoms survey taken at baseline (at clinic visit) and at set time points post urine testing

  1 year

• Overall cost

  1 year

Study Arms (2)

A-Culture and Sensitivity group

ACTIVE COMPARATOR

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

Other: culture versus Molecular diagnostics

B-Diagnosis by Molecular Testing

ACTIVE COMPARATOR

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

Other: culture versus Molecular diagnostics

Interventions

culture versus Molecular diagnostics OTHER

Treatment based on the results of the FH C \& S testing - Odd Numbers on randomization table

A-Culture and Sensitivity group; B-Diagnosis by Molecular Testing

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southwest Regional PCR, LLC: lead

Study Officials

• Michael McDonald, MD

  Florida Hospital Celebration Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 7, 2015
• Study Start: January 15, 2016
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: October 5, 2017

Record last verified: 2017-10