This prospective single-center, single-arm clinical trial will be conducted to study the
initiation of a new diagnostic pathway for acute respiratory illness. After confirming
eligibility following ED triage, patients will be enrolled to undergo the Spotfire syndromic
assessment (Biomerieux, Inc.). Samples for the test will be collected via a nasopharyngeal
swab administered by triage nurse or ED technician in triage. Results from test will be
available in approximately 15 minutes. Patients with signs and symptoms of sore throat
determined by throat pain or exudates on tonsils will also be tested for Group A
streptococcus at enrollment.
Prior to enrollment, the research team asked the initial clinician to delay ordering
additional tests until the test was resulted.
Patients who present to the ED with complaints of ARI will be considered eligible for the
study. The intervention involves the use of a rapid point-of-care multiplex PCR test
(Spotfire) to identify etiology of patients with ARI. Specimen samples will be collected by
research staff at the time of ED presentation. Upon collection, the sample will be promptly
prepared for testing on the SPOTFIRE R Panel device. The device will be in the ED to
facilitate testing and accelerate delivery of diagnostic results to clinicians. The time when
the provider receives the results will be recorded to evaluate the incorporation of results
in clinical decision making.
For providers who do prescribe antibiotics, the investigators will ask for rationale for
antibiotic prescription. Possible causes include: (1) concern for non-respiratory
co-infection; (2) concern for respiratory co-infection. (3) patient request; (4) mitigation
of legal risk. (5) significant co-morbidities. (6) personal preference / long-standing
practice. (7) considered local standard of care. (8) other. In addition to questions above,
investigators will specifically ask if physician was more likely to give antibiotics because
the viral test was negative.
Patients will also be queried about why they came to the ED including if they had a specific
intention to receive antibiotics, additional testing or other reasons.
Both patients and providers will be asked about their confidence in diagnosis, importance of
getting results same day.
The investigators will record the time of triage, time of nasopharyngeal swab, time of test
results and time communicated with clinician and time that any additional tests are ordered.
The results of the test include the presence of any pathogens.
After discharge, patient will receive a chart review, including ICD-10 code, disposition,
summary of test results, Strep test ordered and resulted, antibiotics given in ED (and time),
ED length of stay, ED discharge, additional diagnostic tests (i.e., chest X-ray, other lab
tests.)
The trial was designed to measure the antibiotic prescribing rate for subjects with a
definitive viral etiology, a definitive bacterial etiology and no etiology identified. The
study team planned an analysis to assess the antibiotic prescribing rate of those with a
definitive viral infection versus those with no etiology identified or bacterial origin.
For all consented and tested patients, the investigators will record baseline patient
demographics and characteristics. Group data will be compared for equality and inequality of
variances, and for non-normality. Continuous variables between groups will be compared by
their means using appropriate t-tests after testing for equality of variances. Discrete or
categorical variables will be compared between groups by their proportions using chi-square
tests. Non-normal data will be tested using non-parametric tests where appropriate. The
testing of the difference between groups of some outcome variables will be done with
adjustment for their baseline measures. Either an Analysis of Covariance for continuous data
or a logistic regression for discrete data will be used as appropriate for these procedures.
A minimum significance interval of 0.05 will be used for all comparison tests.