TEM-PCR™ Prospective Clinical Utility Study

PHASE4SuspendedINTERVENTIONAL
Enrollment

314

Participants

Timeline

Start Date

March 6, 2020

Primary Completion Date

May 31, 2022

Study Completion Date

May 31, 2022

Conditions
Upper Resp Tract Infection
Interventions
DIAGNOSTIC_TEST

TEM-PCR URI Panel

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.

OTHER

SOC/Empiric Diagnosis

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.

Trial Locations (4)

35613

Twilight Medical Center, Athens

Valley Internal Medicine, Athens

35801

Blankenship Family Medicine, Huntsville

35808

Comprehensive Primary Care and Urgent Care of Alabama, Huntsville

Sponsors
All Listed Sponsors
lead

Diatherix Laboratories, LLC

INDUSTRY

NCT04248361 - TEM-PCR™ Prospective Clinical Utility Study | Biotech Hunter | Biotech Hunter