## Protocol Section
### Identification Module
**NCT ID:** NCT02623179

**Brief Title:** Conventional and Molecular Diagnostic Method for Patients With Suspected UTI

**Official Title:** Conventional and Molecular Diagnostic Method for Patients With Suspected Urinary Tract Infections: Clinical, Economic, and Quality of Life Outcomes

#### Organization Study ID Info
**ID:** PATUTI
#### Organization
**Class:** INDUSTRY
**Full Name:** Southwest Regional PCR, LLC
### Status Module
#### Completion Date
**Date:** 2016-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-10-05

**Type:** ACTUAL

**Last Update Submit Date:** 2017-10-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2016-01-15

**Type:** ACTUAL

**Status Verified Date:** 2017-10

#### Study First Post Date
**Date:** 2015-12-07
**Type:** ESTIMATED
**Study First Submit Date:** 2015-12-01
**Study First Submit QC Date:** 2015-12-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Southwest Regional PCR, LLC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Urinary Tract Infections-UTI

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: culture versus Molecular diagnostics

**Label:** A-Culture and Sensitivity group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Other: culture versus Molecular diagnostics

**Label:** B-Diagnosis by Molecular Testing

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- A-Culture and Sensitivity group

- B-Diagnosis by Molecular Testing

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

**Name:** culture versus Molecular diagnostics

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** comparison of culture and sensitivity results to the molecular results

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

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** time from collection of sample to diagnostic result delivery

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

**Time Frame:** 1 year

**Description:** collect time of reported UTI from Subject

**Measure:** Time from participant reported start of UTI symptoms to resolution.

**Time Frame:** 1 year

**Description:** collect data from Subject as outlined in the Quality of Life Assessment

**Measure:** 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

**Time Frame:** 1 year

**Description:** collect data on the overall cost of Subject treatment

**Measure:** Overall cost

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 89 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Florida Hospital Celebration Health

**Name:** Michael McDonald, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17302

- Name: Urinary Tract Infections

- Relevance: HIGH

- As Found: Urinary Tract Infections

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000014552

- Term: Urinary Tract Infections

### Misc Info Module

- Version Holder: 2024-05-24
