Actively Recruiting
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?
Led by The University of Texas Health Science Center, Houston · Updated on 2026-01-23
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center, Houston
Lead Sponsor
M
MeMed Diagnostics Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether adding a diagnostic test that can distinguish whether an acute respiratory illness is caused by bacteria or viruses early in the evaluation can improve patient management and reduce healthcare resource use. The study focuses on adults presenting to the Emergency Department (ED) with undiagnosed respiratory infections who meet SIRS criteria and require immediate blood tests and treatment. The goal is to see if this test affects decisions about further diagnostic work, antimicrobial use, hospital stay length, and related costs. Participants are randomly assigned to one of two groups. The experimental group receives the usual care plus results from the MeMed BV ae biomarker test, which analyzes a blood sample to provide a score that may help guide treatment. The control group receives standard care without the test results. Both groups are managed by clinicians following standard practice protocols. The study aims to compare outcomes such as additional testing, use of antibiotics, hospital admissions, and length of stay between these groups. During the study, participants will be monitored from admission to the ED through about 28 days of follow-up. Researchers will track costs related to diagnostic tests, consultations, antimicrobial treatments, hospital stays, and emergency department visits. They will also assess hospital length of stay up to six months post-admission, the number of patients returning to the ED within 72 hours, and appropriate antibiotic use based on infection type. Safety and patient management quality will be evaluated by reviewing these clinical and resource measures.
CONDITIONS
Brief Title
An Adjunct Test Distinguishing Bacterial From Viral Etiology Improves Resource Utilization and Efficiency in the ED.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Current disease duration is 7 days or less
- Temperature of 37.8°C (100°F) or higher, 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 obtained from patient or legal guardian
- Clinical suspicion of bacterial or viral sepsis based on 2 or more SIRS criteria or RTI with fever as above
You will not qualify if you...
- Systemic antibiotics taken up to 48 hours prior to presentation
- Outpatient steroids taken within 48 hours prior to presentation
- Suspicion or confirmed diagnosis of infectious gastroenteritis or colitis
- Inflammatory diseases such as IBD, SLE, RA, or vasculitis
- Congenital immune deficiency
- Proven or suspected infection with Mycobacterial, parasitic, or fungal pathogens
- HIV, Hepatitis B, or Hepatitis C infection
- Major trauma or burns within the last 7 days
- Major surgery within the last 7 days
- Pregnancy, self-reported or medically confirmed
- Active malignancy diagnosed within the last six months or not in remission
- Current treatment with immune-suppressive or immune-modulating therapies within the past 10 days
- Hemodynamically unstable requiring life-saving interventions
- Patients transferred from another facility with a known respiratory diagnosis
- Considered unsuitable for the study by the study team
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person at the Emergency Department)
Duration - Up to 48 hours from admission
Participants undergo standard diagnostic tests for acute respiratory infections, including blood draws and other usual care diagnostics. The experimental group also has an additional blood test that helps distinguish bacterial from viral infections.
1 visit (in-person at the Emergency Department)
Duration - Up to about 28 days from admission
Participants are observed for clinical outcomes including hospital admission, length of stay, and resource utilization such as consults and treatments over the course of the study.
Follow-up contacts and assessments as part of the 28-day monitoring period
Duration - From 28 days up to 6 months from baseline
Participants have extended follow-up for hospital length of stay and any bounce-back visits to evaluate longer-term outcomes.
Additional follow-up visits or contacts as needed
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
David Robinson, MD,MS,MMM
N
Neomi Sepulveda
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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