Respiratory Tract InfectionsNCT06070688
An Adjunct Test Distinguishing Bacterial From Viral Etiology Improves Resource Utilization and Efficiency in the ED.
A study testing MeMed BV® biomarker test in people with Respiratory Tract Infections, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- MeMed BV® biomarker test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
David Robinson, MD,MS,MMM, 713-500-7873, David.J.Robinson@uth.tmc.edu
Neomi Sepulveda, 713.500.8474, Neomi.Sepulveda@uth.tmc.edu
About this study
Official title: 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)
Read the 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
- Being tested
- MeMed BV® biomarker test, Usual care
- Keywords
- bacterial infection, viral infection
- Medical subject headings
- Respiratory Tract Infections, Bacterial Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeMed BV® biomarker testDiagnostic 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 careDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: end of study (about 28 days from baseline)
Length of hospital stay
Comparative metric between the experimental and control groups
Measured: at time of discharge( from 28 days- 6months from baseline)
Secondary outcomes (6)
Length of stay in emergency department
Comparative metric between the experimental and control groups
Measured: 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
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
Measured: end of study (about 28 days from baseline)
Emergency room work-up costs
Comparative metric between the experimental and control groups
Measured: 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
Comparative metric between the experimental and control groups
Measured: 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
Comparative metric between the experimental and control groups
Measured: Within 1-3 hours of admission to emergency department
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
Comparative metric between the experimental and control groups
Measured: end of study (about 28 days from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start11 Dec 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- MeMed Diagnostics Ltd.
- Responsible party
- Principal investigator, David Robinson, The University of Texas Health Science Center, Houston
- Investigators
- David Robinson, MD,MS,MMM, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070688
- Sponsor's protocol ID
- HSC-MS-23-0692
- Status last verified
- Jan 2026
- First submitted
- 2 Oct 2023
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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?
- ClinicalTrials.gov ID
- NCT06070688
- Acronym / sponsor ID
- HSC-MS-23-0692
- Conditions
- Respiratory Tract Infections
- Keywords
- bacterial infection, viral infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- MeMed Diagnostics Ltd.
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MeMed BV® biomarker test and standard of care | Experimental | Diagnostic Test: MeMed BV® biomarker test, Diagnostic Test: Usual careIn 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. |
| Usual Care | Active comparator | Diagnostic Test: Usual careThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeMed BV® biomarker testone 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 | MeMed BV® biomarker test and standard of care |
| Usual careUsual 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. | Diagnostic test | MeMed BV® biomarker test and standard of care, Usual Care |
Primary outcome
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
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
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
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
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
Length of hospital stay
Time frame: at time of discharge( from 28 days- 6months from baseline)
Comparative metric between the experimental and control groups
6 secondary outcomes
Length of stay in emergency department
Time frame: 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)
Emergency room work-up costs
Time frame: 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
Time frame: 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
Time frame: Within 1-3 hours of admission to emergency department
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Robinson, MD,MS,MMM principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MeMed BV® biomarker test in people with Respiratory Tract Infections, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Robinson, MD,MS,MMM ((713) 500-7873, David.J.Robinson@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.