Respiratory Tract Infections Clinical Trial
Official title:
Behavioral Patterns and Patient Self-completed Diagnostic Testing Study of Respiratory Viral Infection "Home Testing of Respiratory Illness"
The main goal of this research study is to use data from activity trackers (such as Fitbits), lab tests, and surveys to see if activity, sleep, and heart rate data can tell the difference between when someone has a respiratory illness (e.g., flu) and when they are feeling healthy. The research will also study an investigational flu@home test and app. If successful, results from the study could be used in the future to better identify people with respiratory illness. In addition, this study will test the accuracy of an at-home flu test kit compared to laboratory test results.
Background and Rationale
Acute respiratory infections (ARI) cause considerable disease burden globally and can affect
both the upper and lower respiratory tract. A majority of ARI are caused by viruses, like the
influenza virus, while bacteria are only implicated in approximately 10% of cases . The
symptomology across various viral ARI are broadly similar, but two viruses, namely influenza
and respiratory syncytial virus (RSV) are associated with considerable morbidity and
mortality among adults and children. More immediate virus identification would improve
patient health management by triaging appropriate and timely treatment and infection-control
measures to mitigate health costs, additional health complications, and total days of symptom
expression.
Despite viral infections causing the majority of ARIs, 61% of those with acute respiratory
symptoms receive an antibiotic treatment. Due to the rise of antibiotic resistance, the
inappropriate and over-prescription of antibiotics has become a severe health risk and is
contributing to greater health complications and increased mortality rates. As a result, the
correct diagnosis of the various infections associated with ARIs has become even more
imperative to not cause undue harm. The abundance, accessibility, and rapidly advancing
technology in wearable devices contributes to the progress some studies have demonstrated in
using the devices as a potential mechanism to more rapidly identify various diseases. Though
limited research has explored this new perspective specifically in illnesses associated with
ARI, recent findings were able to demonstrate influenza signals at a population level using
step, sleep, and heart rate data collected from consumer wearable devices.
Influenza virus is important to diagnose correctly because, despite annual vaccinations, it
has been associated with higher morbidity and mortality than most other ARI viruses and has
been associated with greater individual symptom severity. During the 2017-2018 flu season in
the United States, it was estimated that 48.8 million people became sick with influenza,
959,000 were hospitalized, and there were 79,400 deaths recorded due to influenza.
Additionally, more vulnerable populations, like young children, those experiencing chronic
illness, and older adults, disproportionately represent the hospitalization and death totals
reported. Older adults represented 70% of influenza related hospitalizations in the 2017-2018
flu season and 90% of influenza related deaths.
The rapid diagnosis of influenza is also of particular importance due to the effectiveness of
influenza antiviral medication that is largely limited to initiation within 48 hours of
symptom onset. Additionally, rapid diagnosis also has the potential to enact infection
control measures to attenuate viral spread, particularly among vulnerable populations, using
behavioral interventions or other non-pharmaceutical approaches. Diagnosis of influenza
infection in centralized laboratories has largely progressed from traditional viral culture
to the use of reverse transcription-polymerase chain reaction (RT-PCR) methods .
Alternatively, influenza infection can be detected within a medical office or pharmacy using
commercially-available rapid diagnostic tests (RDTs) of varying complexity, cost and
accuracy.
There is now interest to expand RDTs to self-conducted tests that individuals can complete at
home to further reduce the period between the onset of illness and effective treatment.
Audere, a digital health non-profit, developed a mobile device app, the flu@home app, to
guide individuals to perform an influenza RDT themselves without being in a clinical setting.
The flu@home test uses a mixture of images and written directions prompted through the
flu@home app to walk individuals through an influenza RDT process. The flu@home test also
includes modified influenza RDT test material from an FDA 510(k) cleared RDT and includes an
optional in-app automated influenza RDT test result interpretation system to eventually help
inform health decisions and behaviors. Though no research has been published on the efficacy
of the flu@home system, it has been implemented, and is being investigated, in two large
prospective observational clinical studies during the 2019-2020 flu season, with
collaborators at the University of Washington, Seattle and University of Adelaide, Australia.
Expanding on the previous research and development that has been done, the aim of this study
is to develop a methodology to better classify and detect RVI cases, including influenza,
through the use of behavioral data and patient-reported outcomes, using RVI confirmation
through laboratory testing as a reference. This study also aims to assess the accuracy of the
flu@home RDT self-test, the in-app automated RDT test result interpretation, and a data
enhanced RDT test interpretation, compared to the interpretation provided by a trained
professional RDT reader, the PCR test result, and a reference influenza test
interpretations/analysis.
Device Description
The flu@home test kit is an at-home self-administered modified influenza RDT that is
completed with the assistance of a mobile device app. The flu@home app feature was developed
by Audere, a digital health non-profit based in Seattle. The flu@home test consists of the
instructional app experience that guides participants through the influenza RDT procedure and
the physical material of the RDT influenza test kit modified from the Quidel QuickVue
Influenza A+B test. The flu@home app will solely be utilized as an instructional guide and
research data collection tool for this study.
The flu@home test kit's instructional app features are available on iOS and Android
platforms. The instructional app features include multiple pages of text and imagery content
guiding participants through the entirety of the influenza RDT process, from completing a
nasal swab to adding solution into a test tube to run a lateral flow immunoassay. The
instructional app also includes an in-app questionnaire for participants to complete during a
10-minute participant wait period while their immunoassay processes. The flu@home test kit
also guides participants through the viral collection and appropriate transport procedure of
study samples for additional RVI analysis to be completed at an accredited laboratory.
The physical material of the flu@home test kit consists of components from an existing
commercial influenza RDT, with additional material to collect and return a reference sample
for laboratory testing. The complete flu@home test kit includes two foam-tipped nasal swabs,
a small tube with dried reagent, a saline vial, a lateral-flow immunoassay test strip, and a
tube with liquid reagent for the PCR test. RDT testing material is utilized from the
CLIA-waived Quidel QuickVue Influenza A+B Test. All physical testing material will be
assembled and mailed to participants through a 3rd party vendor, Molecular Testing Lab (MTL).
The flu@home test kit also includes mailing material for participants to return the RDT test
remnant and strip to be discarded by MTL and the reference nasal swab for laboratory testing
through PCR procedures at MTL's accredited facility.
The flu@home test kit's interpretation features will not be shared with participants within
the parameters of this study.
Regulatory Status
The flu@home test kit is considered a non-significant investigational device that is being
used for data collection purposes and will be labeled as an investigational device. The test
kit contains foam-tipped nasal swabs, a small tube with dried reagent, a saline vial and test
strip from the CLIA-waived Quidel QuickVue Influenza A+B Test, and a tube with liquid reagent
for the PCR test.
Explanation of choice comparator
PCR (RT-PCR for RNA viruses including influenza) is a reliable reference test for influenza
and other respiratory viruses. RT-PCR was identified as the comparator for the modified
at-home self-administered influenza RDT. Though RDTs can produce results in a much shorter
period of time than RT-PCRs, RT-PCRs have been found to have more sensitivity to the
influenza viruses than do RDTs. PCR or RT-PCR is often used as the reference test in research
studies and studies designed for FDA submission (e.g., influenza RT-PCR was used as a
reference test in the FDA 510(k) submission for the Quidel QuickVue Influenza A+B Test;
Quidel, 2018).
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