TEM-PCR™ Prospective Clinical Utility Study

NCT04248361 | Suspended Phase 4 FDA Device

• 1 other identifier: Diatherix-601
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 4

Brief Summary

This is a randomized, open-label, multi-center, prospective study to assess the clinical utility of the TEM-PCR Upper Respiratory Infection (URI) Panel in adult subjects age 65 and older presenting to the primary care clinic with symptoms of acute respiratory illness.

Conditions

Upper Resp Tract Infection

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with revisit to a healthcare facility

  The rate of revisit to a healthcare facility (i.e., revisit to primary care, urgent care, or hospital ER) for the same reason (respiratory infection) as the initial visit between subjects assigned to SOC/empiric diagnosis and TEM-PCR diagnosis as well as in a subset of subjects with bacterial superinfection

  30 days

Secondary Outcomes (15)

• Proportion of subjects prescribed antibiotics on Day 1 for respiratory infection

  30 days

• Proportion of subjects prescribed or continuing antibiotics for respiratory infection on the day of pathogen diagnosis

  30 days

• Total number of days of antibiotic use for respiratory infection during the follow-up period

  30 days

• Appropriateness of initial antibiotic selection for respiratory infection

  30 days

• Proportion of subjects prescribed antivirals (i.e., oseltamivir, zanamivir, etc.) for respiratory infection on Day 1

  30 days

Study Arms (2)

TEM-PCR Diagnosis

EXPERIMENTAL

The TEM-PCR diagnostic technology will be used to assess for a source pathogen involved in the subject's acute respiratory illness. Results of the TEM-PCR URI Panel will be used by the physician to guide treatment decisions. If indicated, the investigator may also utilize rapid strep testing and rapid influenza testing for diagnosis. In the event a lower respiratory infection is suspected a chest x-ray or complete blood count (CBC) with differential may also be performed.

Diagnostic Test: TEM-PCR URI Panel

SOC/Empiric Diagnosis

ACTIVE COMPARATOR

The Standard of Care for upper respiratory infection may include, but is not limited to, rapid strep testing, rapid influenza testing, and sputum cultures. In the event a lower respiratory infection is suspected a chest x-ray or CBC with differential may be performed.

Other: SOC/Empiric Diagnosis

Interventions

TEM-PCR URI Panel DIAGNOSTIC_TEST

Target Enriched Multiplex Polymerase Chain Reaction (TEM-PCR™) is a breakthrough molecular multiplex technology that allows rapid DNA/RNA identification of multiple pathogens (i.e., bacteria and viruses) in a single sample, typically within one day of specimen receipt.

TEM-PCR Diagnosis

SOC/Empiric Diagnosis OTHER

The SOC for upper respiratory infection may include, but is not limited to, rapid strep testing, rapid influenza testing, and sputum cultures. In the event a lower respiratory infection is suspected a chest x-ray or CBC with differential may be performed.

SOC/Empiric Diagnosis

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Provide written informed consent for the trial;
• Age 65 years or older;
• In the opinion of the investigator, subject has the cognitive ability to provide accurate information to study site personnel and to follow instructions, or subject has a caregiver who can provide accurate information and ensure subject's compliance with instructions;
• Presentation with at least two of the following symptoms of acute respiratory illness:
• nasal congestion
• chest congestion
• shortness of breath
• cough
• body ache
• fever (≥100.4 ºF)

You may not qualify if:

• Subject is currently taking antibiotics or has taken antibiotics within the previous 30 days.
• Subject is currently taking antivirals or has taken antivirals within the previous 30 days.
• Subject has been hospitalized within the previous 30 days.
• Severity of illness (according to the Investigator) requires immediate hospitalization or referral to specialty care.

Sponsors & Collaborators

• Diatherix Laboratories, LLC: lead

Study Sites (4)

Twilight Medical Center

Athens, Alabama, 35613, United States

Location

Valley Internal Medicine

Athens, Alabama, 35613, United States

Location

Blankenship Family Medicine

Huntsville, Alabama, 35801, United States

Location

Comprehensive Primary Care and Urgent Care of Alabama

Huntsville, Alabama, 35808, United States

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Ali Hassoun, MD

  Alabama Infectious Disease Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Open-label, Multi-Center, Prospective Study

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 30, 2020
• Study Start: March 6, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: August 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)