RecruitingNot ApplicableNCT06070688

An Adjunct Test Distinguishing Bacterial From Viral Etiology Improves Resource Utilization and Efficiency in the ED.

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?

Sponsor

The University of Texas Health Science Center, Houston

Enrollment

100 participants

Start Date

Dec 11, 2023

Study Type

INTERVENTIONAL

Conditions

Respiratory Tract Infections

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)

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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)
Written informed consent must be obtained from the patient or his/her legal guardian
Current disease duration ≤ 7 days
Clinical suspicion of bacterial or viral sepsis based on 2 or more SIRS criteria OR Clinical suspicion of bacterial or viral respiratory tract infection (RTI) AND temperature ≥ 37.8°C (100°F) or tactile fever, noted at least once within the last 7 days

Exclusion Criteria29

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 infection on the presentation with Mycobacterial, parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen
Human immunodeficiency virus(HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (self-declared or known from medical records)
Major trauma and/or burns in the last 7 days
Major surgery in the last 7 days
Pregnancy - Self reported or medically confirmed
Active malignancy - Cancer diagnosed within the previous six months, recurrent, regionally advanced, or metastatic cancer, cancer for which treatment had been administered within six months, or hematological cancer that is not in complete remission.
Current treatment with immune-suppressive or immune-modulating therapies, at some point in the past 10 days
Hemodynamically unstable (require life-saving interventions such as vasopressors)
Patients transferred from another facility who already have a differentiated respiratory illness (known diagnosis e.g., culture positive results)
Consider unsuitable for the study by the study team
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 (e.g., IBD, SLE, RA, other vasculitis)
Congenital immune deficiency (CID)
A proven or suspected infection on the presentation with Mycobacterial (e.g., MAC, MABC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen
HIV, HBV, or HCV infection (self-declared or known from medical records)
Major trauma and/or burns in the last 7 days
Major surgery in the last 7 days
Pregnancy - Self reported or medically confirmed
Active malignancy of a solid tumor - Cancer diagnosed within the previous six months, recurrent, regionally advanced, or metastatic cancer, cancer for which treatment had been administered within six months, or hematological cancer that is not in complete remission
Current treatment with immune-suppressive or immune-modulating therapies, at some point in the past 10 days
Hemodynamically unstable (require life-saving interventions such as vasopressors)
Patients transferred from another facility who already have a differentiated respiratory illness (known diagnosis e.g., culture positive results)

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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.