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.
This is a randomized, open-label, multi-center, prospective study to assess the clinical utility of the TEM-PCR URI Panel in adult subjects age 65 and older presenting to the primary care clinic with symptoms of acute respiratory illness. The study will enroll 314 subjects with \<10% of subjects having chronic conditions that may affect the lungs (i.e., CHF, COPD, and neoplastic disease of the lungs). Subjects recruited from the general patient population visiting identified primary care clinic sites will be recruited and randomized to either TEM-PCR or Standard of Care (SOC)/empiric diagnosis for determination of respiratory pathogen(s). The treating physician will use the results of either the TEM-PCR panel or the SOC/empiric diagnosis to guide treatment decisions. Sputum sample (or nasopharyngeal swab if sputum sample cannot be collected) results obtained from the TEM-PCR diagnosis will be available in approximately one business day of sample collection. Sputum sample (or nasopharyngeal swab if sputum sample cannot be collected) results obtained from the SOC/empiric diagnosis will be available in approximately 3-5 business days of sample collection. The Investigator may call the subject upon receipt of sputum sample results if the results indicate that a change in therapy is necessary. All changes in the prescribed treatment plan will be documented in the subject's source documents. Subjects will record all therapy used for the treatment of respiratory illness and adverse events from Day 1 through Day 30 in a patient diary. A final in-clinic visit will be conducted on Day 30 (± 5 days) following the Day 1 clinic visit to assess for outcomes (i.e., antibiotic treatment and duration/completion, use of antivirals and duration/completion, rate of clinic revisit or hospital admission and subsequent length of stay, mortality rate, use of steroids and/or antipyretics, use of OTC symptomatic treatments, and use of supportive therapy).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
314
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.
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.
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
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
Time frame: 30 days
Proportion of subjects prescribed antibiotics on Day 1 for respiratory infection
Time frame: 30 days
Proportion of subjects prescribed or continuing antibiotics for respiratory infection on the day of pathogen diagnosis
Time frame: 30 days
Total number of days of antibiotic use for respiratory infection during the follow-up period
Time frame: 30 days
Appropriateness of initial antibiotic selection for respiratory infection
Appropriateness will be determined by the investigator based upon pathogen sensitivity to the initial antibiotic selection as determined by sputum culture results.
Time frame: 30 days
Proportion of subjects prescribed antivirals (i.e., oseltamivir, zanamivir, etc.) for respiratory infection on Day 1
Time frame: 30 days
Proportion of subjects prescribed or continuing antivirals for respiratory infection on the day of pathogen diagnosis
Time frame: 30 days
Total number of days of antiviral use for respiratory infection during the follow-up period
Time frame: 30 days
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Appropriateness of initial antiviral selection for respiratory infection
Appropriateness will be determined by the investigator based upon pathogen sensitivity to the initial antiviral selection as determined by sputum culture results.
Time frame: 30 days
Hospital admission for respiratory infection
The subject will be assessed as to whether or not they were admitted to a hospital during the time from the initial clinic visit until the final Day 30 clinic visit.
Time frame: 30 days
Mortality from any cause within 30 days of Clinic visit
Time frame: 30days
Clearance of respiratory infection at 30 days
The investigator will assess the patient via a directed physical exam to assess whether the patient's respiratory infection has resolved. This assessment will be conducted at the Day 30 visit.
Time frame: 30 days
Use (or increase in use) of steroids and/or antipyretics (acetaminophen/NSAIDs) for the treatment of respiratory illness
Time frame: 30 days
Use of OTC symptomatic treatment (i.e., antitussives, decongestants, and antihistamines) for the treatment of respiratory illness
Time frame: 30 days
Use of supportive care (i.e., mechanical ventilation, addition of oxygen therapy or increase in oxygen use)
Time frame: 30 days
Length of hospital stay for respiratory infection
If a subject is admitted to the hospital for respiratory infection at any point from the initial clinic visit until the final Day 30 clinic visit, the length of the admission (in days) will be recorded.
Time frame: 30 days