Actively Recruiting
An Adjunct Test Distinguishing Bacterial From Viral Etiology Improves Resource Utilization and Efficiency in the ED.
Led by The University of Texas Health Science Center, Houston · Updated on 2026-01-23
100
Participants Needed
1
Research Sites
159 weeks
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
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
Official 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...
- Disease duration of 7 days or less
- Fever of at least 37.86C (1006F) or tactile fever noted at least once in the past 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 bacterial or viral RTI with fever of at least 37.86C (1006F) or tactile fever
You will not qualify if you...
- Use of systemic antibiotics within 48 hours prior to presentation
- Use of outpatient steroids within 48 hours prior to presentation
- Suspicion or diagnosis of infectious gastroenteritis or colitis
- Presence of inflammatory diseases such as IBD, SLE, RA, or other vasculitis
- Congenital immune deficiency
- Proven or suspected infection with mycobacterial, parasitic, or fungal pathogens
- Known or self-declared HIV, HBV, or HCV infection
- Major trauma or burns within the past 7 days
- Major surgery within the past 7 days
- Pregnancy (self-reported or medically confirmed)
- Active malignancy diagnosed within the past 6 months or recurrent, advanced, or metastatic cancer
- Treatment with immune-suppressive or immune-modulating therapies within the past 10 days
- Hemodynamically unstable requiring life-saving interventions such as vasopressors
- Transfer from another facility with a known differentiated respiratory illness
- Considered unsuitable for study participation by the study team
AI-Screening
AI-Powered Screening
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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
CONTACT
N
Neomi Sepulveda
CONTACT
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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