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

NCT06070688 | Recruiting FDA Device

• 1 other identifier: HSC-MS-23-0692
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Conditions

Respiratory Tract Infections

Keywords

bacterial infection; viral infection

Outcome Measures

Primary Outcomes (6)

• Cost of any additional diagnostic tests done by a participant

  Additional diagnostic tests may include serial complete blood count (CBC)s, additional blood cultures, viral cultures and serial basic metabolic panel (BMP) blood bank

  from day of admission to emergency department upto about 28 day follow up

• Cost of any additional consults done by a participant

  Comparative metric between the experimental and control groups

  from day of day of admission to emergency department upto about 28 day follow up

• Total cost of any antimicrobial treatments by a participant

  Comparative metric between the experimental and control groups

  end of study (about 28 days from baseline)

• Number of participants that were admitted to the hospital

  Comparative metric between the experimental and control groups

  end of study (about 28 days from baseline)

• Cost of hospital stay

  Total costs defined as all costs including lab and diagnostic services, blood bank, pharmaceuticals, nursing, consultants, and all other services listed in the patient's work-up. Comparative metric between the experimental and control groups

  end of study (about 28 days from baseline)

• Length of hospital stay

  Comparative metric between the experimental and control groups

  at time of discharge( from 28 days- 6months from baseline)

Secondary Outcomes (6)

• Length of stay in emergency department

  at time of discharge from emergency department (upto about 48 hours form admission)

• Number of participants that had a bounce back as defined as patients returning any time during the 28-day call back period

  end of study (about 28 days from baseline)

• Emergency room work-up costs

  at time of discharge from emergency department (upto about 48 hours form admission)

• Number of participants with medical interventions such as blood draws, consults and imaging used during the patient's time in the study

  end of study (about 28 days from baseline)

• Quality of care as determined by the number of acute respiratory ill patients with bacterial etiology that received appropriate antibiotics

  Within 1-3 hours of admission to emergency department

Study Arms (2)

MeMed BV® biomarker test and standard of care

EXPERIMENTAL

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.

Diagnostic Test: MeMed BV® biomarker test; Diagnostic Test: Usual care

Usual Care

ACTIVE COMPARATOR

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.

Diagnostic Test: Usual care

Interventions

Usual care 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.

MeMed BV® biomarker test and standard of care; Usual Care

MeMed BV® biomarker test 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.

MeMed BV® biomarker test and standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• MeMed Diagnostics Ltd.: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections; Bacterial Infections; Virus Diseases

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Bacterial Infections and Mycoses

Study Officials

• David Robinson, MD,MS,MMM

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Robinson, MD,MS,MMM

CONTACT

(713) 500-7873; David.J.Robinson@uth.tmc.edu

Neomi Sepulveda

CONTACT

713.500.8474; Neomi.Sepulveda@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Statistician assessing financial and resource utilization between study arms (primary and secondary outcomes) will be blinded as to which cohort had the results of the Memed diagnostic test (experimental vs standard groups)
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 6, 2023
• Study Start: December 11, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)