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 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)
Key Trial Info
Start Date :
December 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06070688
Start Date
December 11 2023
End Date
December 31 2026
Last Update
January 23 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030