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

January 21, 2026 updated by: David Robinson, The University of Texas Health Science Center, Houston

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 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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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

Inclusion Criteria for Subgroup:

  • 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

Patients fulfilling one or more of the following exclusion criteria from the main group are eligible for the subgroup cohort:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Diagnostic test: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cost of any additional diagnostic tests done by a participant
Time Frame: from day of admission to emergency department upto about 28 day follow up
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
Time Frame: from day of day of admission to emergency department upto about 28 day follow up
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
Time Frame: end of study (about 28 days from baseline)
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
Time Frame: end of study (about 28 days from baseline)
Comparative metric between the experimental and control groups
end of study (about 28 days from baseline)
Cost of hospital stay
Time Frame: end of study (about 28 days from baseline)
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
Time Frame: at time of discharge( from 28 days- 6months from baseline)
Comparative metric between the experimental and control groups
at time of discharge( from 28 days- 6months from baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of stay in emergency department
Time Frame: at time of discharge from emergency department (upto about 48 hours form admission)
Comparative metric between the experimental and control groups
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
Time Frame: end of study (about 28 days from baseline)
Bounce backs are defined as any return to a health care entity during the 28 day period after discharge from the index visit. Comparative metric between the experimental and control groups
end of study (about 28 days from baseline)
Emergency room work-up costs
Time Frame: at time of discharge from emergency department (upto about 48 hours form admission)
Comparative metric between the experimental and control groups
at time of discharge from emergency department (upto about 48 hours form admission)
Quality of care as determined by the number of acute respiratory ill patients with bacterial etiology that received appropriate antibiotics
Time Frame: Within 1-3 hours of admission to emergency department
Comparative metric between the experimental and control groups
Within 1-3 hours of admission to emergency department
Number of participants with medical interventions such as blood draws, consults and imaging used during the patient's time in the study
Time Frame: end of study (about 28 days from baseline)
Comparative metric between the experimental and control groups
end of study (about 28 days from baseline)
Number of participants within the upper respiratory infection (URI) cohort without a bacterial source (viral, inflammatory, etc.) who appropriately did not receive antibiotics or whose antibiotic course was withheld during the patient's time in the study
Time Frame: end of study (about 28 days from baseline)
Comparative metric between the experimental and control groups
end of study (about 28 days from baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
MeMed Diagnostics Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Robinson, MD,MS,MMM, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-23-0692

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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