An Adjunct Test Distinguishing Bacterial From Viral Etiology Improves Resource Utilization and Efficiency in the ED.

Respiratory Tract Infections Clinical Trial

Official title: 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?

Status Recruiting

Clinical Trial 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 (including other diagnostic tests and consults), antimicrobial treatments, disposition decisions and hospital length of stay (LOS)

Clinical Trial 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 evaluated through the Emergency Department (ED) as an undiagnosed acute reparatory illness (URI). The included patient cohort must present with SIRS criteria and be ill enough to require immediate blood draw and management by the ED. Excluded are any URIs with a predetermined diagnosis or subjects presenting with illness not determined to be a URI as a primary diagnosis. The experimental arm of the study shall have in addition to the standard of care labs and diagnostics, a novel protein array blood test that can distinguish bacterial from viral disease. The control group will not receive these results. The trial seeks to examine the difference in clinical outcomes when a adjunct biomarker than can help the clinician guide more accurate therapy is available early in the diagnostic workup. Benefits are defined in the primary and secondary outcomes as reduced resources expended through reduced laboratory, radiological, blood bank, and pharmaceutical expenditures. Comparative resource utilization costs include changes in hospital and or ED length of stay, lower follow up visits and readmissions, less inpatient and outpatient physician consultants and services called for to manage the patients care, and overall costs. Both primary and secondary outcomes will be used to categorize the costs and resources required to manage the patient. Primary objective 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). The exploratory objective is to evaluate changes between control and test arm in ED LOS, bounce backs (patients returning within 72 hours), work-up costs and the impact of physician seniority. ;

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Respiratory Tract Infections

• NCT number: NCT06070688
• Study type: Interventional
• Source: The University of Texas Health Science Center, Houston
• Contact: David Robinson, MD,MS,MMM
• Phone: (713) 500-7873
• Email: David.J.Robinson@uth.tmc.edu
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2023
• Completion date: December 30, 2024