Status:
RECRUITING
An Adjunct Test Distinguishing Bacterial From Viral Etiology Improves Resource Utilization and Efficiency in the ED.
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
MeMed Diagnostics Ltd.
Conditions:
Respiratory Tract Infections
Eligibility:
All Genders
18+ years
Phase:
NA
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 (in...
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 e...
Eligibility Criteria
Inclusion
- 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)
- Blood tests are being ordered
Exclusion
- 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
Key Trial Info
Start Date :
December 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06070688
Start Date
December 11 2023
End Date
December 30 2024
Last Update
May 16 2024
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030