Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06070688

Conditions

Respiratory Tract Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MeMed BV® biomarker test

Usual care

Study Details

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

Study ID

NCT06070688

Start date

Dec 11, 2023

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

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 ]
  • 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 ]
  • Total cost of any antimicrobial treatments by a participant [ Time Frame: 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) ]
  • Cost of hospital stay [ Time Frame: end of study (about 28 days from baseline) ]
  • Length of hospital stay [ Time Frame: at time of discharge( from 28 days- 6months from baseline) ]

Central Contacts and Locations

Central contacts

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Keywords

  • bacterial infection
  • viral infection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-01-23.