Does an Adjunct Diagnostic Test That Can Discriminate Bacterial From Viral Etiology Early in the Management of Respiratory Infections Improve Management Accuracy and Quality in the Acute Care Setting?
The University of Texas Health Science Center, Houston
Summary
The purpose of this study is to evaluate overall changes in patient management and longer-term resource utilization between control and test arms, including (but not limited to) additional work-up (including other diagnostic tests and consults), antimicrobial treatments, disposition decisions and hospital length of stay (LOS)
Description
The trial seeks to compare the benefits of adding a diagnostic test that can distinguish the etiology of an acute respiratory illness early in the work-up and management. All adult patients shall be evaluated through the Emergency Department (ED) as an undiagnosed acute reparatory illness (URI). The included patient cohort must present with SIRS criteria and be ill enough to require immediate blood draw and management by the ED. Excluded are any URIs with a predetermined diagnosis or subjects presenting with illness not determined to be a URI as a primary diagnosis. The experimental arm of the…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria for main study population : * Current disease duration ≤ 7 days * Temperature ≥ 37.8°C (100°F) or tactile fever, noted at least once within the last 7 days * Clinical suspicion of bacterial or viral respiratory tract infection (RTI) Exclusion Criteria for main study population: * Systemic antibiotics taken up to 48 hours prior to presentation * Outpatient steroids taken within 48 hours prior to presentation * Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis * Inflammatory disease * Congenital immune deficiency (CID) * A proven or suspected infect…
Interventions
- Diagnostic TestMeMed BV® biomarker test
one purple top tube of whole blood (2-3 cc) to be used for the MeMed Key® device processing without the need for centrifuge. The MeMed BV® test takes approximately 15 minutes to process and result. After, the sample has been processed and the MeMed BV® test has resulted, the sample of blood will be discarded for each patient enrolled in the study.
- Diagnostic TestUsual care
Usual care includes diagnostic hematology, chemistry, biomarkers, and culture results along with imaging, consults, and medications, in the treatment of acute viral and/or bacterial illness.
Location
- The University of Texas Health Science Center at HoustonHouston, Texas