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

NCT ID: NCT06070688

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-11
• Study Completion Date: 2026-12-31

Brief 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)

Detailed 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 study shall have in addition to the standard of care labs and diagnostics, a novel protein array blood test that can distinguish bacterial from viral disease. The control group will not receive these results. The trial seeks to examine the difference in clinical outcomes when a adjunct biomarker than can help the clinician guide more accurate therapy is available early in the diagnostic workup. Benefits are defined in the primary and secondary outcomes as reduced resources expended through reduced laboratory, radiological, blood bank, and pharmaceutical expenditures. Comparative resource utilization costs include changes in hospital and or ED length of stay, lower follow up visits and readmissions, less inpatient and outpatient physician consultants and services called for to manage the patients care, and overall costs. Both primary and secondary outcomes will be used to categorize the costs and resources required to manage the patient. Primary objective 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). The exploratory objective is to evaluate changes between control and test arm in ED LOS, bounce backs (patients returning within 72 hours), work-up costs and the impact of physician seniority.

Conditions

Respiratory Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

MeMed BV® biomarker test and standard of care

In addition to the standard of care for acute respiratory infections, the experimental arm shall reveal the results of the 'BV' test to the clinician co-investigators. The BV test reports a clinical score from 1-100 that as an adjunct to usual care, may help the clinician better direct appropriate resources towards the patient.

Group Type: EXPERIMENTAL

MeMed BV® biomarker test

Intervention Type: DIAGNOSTIC_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.

Usual care

Intervention Type: DIAGNOSTIC_TEST

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.

Usual Care

The co-investigators shall evaluate, diagnose and manage the acute respiratory infection presenting to the ED using the standard practice known in the community. This may include hospital sepsis practice protocols, clinical judgement, and national or local practice standards.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

MeMed 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.

Intervention Type: DIAGNOSTIC_TEST

Usual 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MeMed Diagnostics Ltd.

INDUSTRY

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

David Robinson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Robinson, MD,MS,MMM

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David Robinson, MD,MS,MMM

Role: CONTACT

David.J.Robinson@uth.tmc.edu

(713) 500-7873

Neomi Sepulveda

Role: CONTACT

Neomi.Sepulveda@uth.tmc.edu

713.500.8474

Facility Contacts

David Robinson, MD,MS,MMM

Role: primary

David.J.Robinson@uth.tmc.edu

713-500-7873

Neomi Sepulveda

Role: backup

Neomi.Sepulveda@uth.tmc.edu

713.500.8474

Other Identifiers

HSC-MS-23-0692

Identifier Type: -

Identifier Source: org_study_id