A test to differentiate between bacterial and viral infections in emergency patients

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?

This study is testing a new blood test to see if it can help doctors tell the difference between bacterial and viral infections in adults with respiratory illnesses in the emergency room.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The University of Texas Health Science Center, Houston (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06070688 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of a novel protein array blood test that distinguishes bacterial from viral respiratory infections in patients presenting to the Emergency Department with acute respiratory illnesses. Adult patients meeting specific criteria will be randomly assigned to either receive the test alongside standard care or to a control group receiving standard care only. The study aims to assess changes in patient management, resource utilization, and clinical outcomes, including length of hospital stay and follow-up visits. By providing early diagnostic information, the trial seeks to improve treatment accuracy and efficiency in managing respiratory infections.

Who should consider this trial

Good fit: Ideal candidates are adults presenting with acute respiratory illnesses who meet specific clinical criteria and require immediate evaluation in the Emergency Department.

Not a fit: Patients with predetermined diagnoses or those presenting with non-respiratory illnesses will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate treatment decisions and reduced healthcare costs for patients with respiratory infections.

How similar studies have performed: Other studies have shown promise in using similar diagnostic approaches to improve patient outcomes, suggesting potential for success in this trial.

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)

Where this trial is running

Houston, Texas

• The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: David Robinson, MD,MS,MMM — The University of Texas Health Science Center, Houston
• Study coordinator: David Robinson, MD,MS,MMM

Conditions Respiratory Tract Infections; bacterial infection; viral infection