TEM-PCR™ Prospective Clinical Utility Study

Paused · Phase 4

Conditions studied: Upper Resp Tract Infection

In brief

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.

Key facts

Study ID

NCT04248361

Run by

Diatherix Laboratories, LLC

People needed

314

Starts

2020-03-06

Expected to finish

2022-05-31

Last updated by the study team

2021-08-20

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Twilight Medical Center — Athens, Alabama, United States
• Valley Internal Medicine — Athens, Alabama, United States
• Blankenship Family Medicine — Huntsville, Alabama, United States
• Comprehensive Primary Care and Urgent Care of Alabama — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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