Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
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 |
Proportion of subjects prescribed antibiotics on Day 1 for respiratory infection |
|
30 days |
|
Secondary |
Proportion of subjects prescribed or continuing antibiotics for respiratory infection on the day of pathogen diagnosis |
|
30 days |
|
Secondary |
Total number of days of antibiotic use for respiratory infection during the follow-up period |
|
30 days |
|
Secondary |
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. |
30 days |
|
Secondary |
Proportion of subjects prescribed antivirals (i.e., oseltamivir, zanamivir, etc.) for respiratory infection on Day 1 |
|
30 days |
|
Secondary |
Proportion of subjects prescribed or continuing antivirals for respiratory infection on the day of pathogen diagnosis |
|
30 days |
|
Secondary |
Total number of days of antiviral use for respiratory infection during the follow-up period |
|
30 days |
|
Secondary |
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. |
30 days |
|
Secondary |
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. |
30 days |
|
Secondary |
Mortality from any cause within 30 days of Clinic visit |
|
30days |
|
Secondary |
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. |
30 days |
|
Secondary |
Use (or increase in use) of steroids and/or antipyretics (acetaminophen/NSAIDs) for the treatment of respiratory illness |
|
30 days |
|
Secondary |
Use of OTC symptomatic treatment (i.e., antitussives, decongestants, and antihistamines) for the treatment of respiratory illness |
|
30 days |
|
Secondary |
Use of supportive care (i.e., mechanical ventilation, addition of oxygen therapy or increase in oxygen use) |
|
30 days |
|
Secondary |
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. |
30 days |
|