Clinical trial NCT06070688: An Adjunct Test Distinguishing Bacterial From Viral Etiology Improves Resource Utilization and Efficiency in the ED.
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?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Tract Infections
Keywords: bacterial infection
viral infection
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: MeMed Diagnostics Ltd.
First posted: 2023-10-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Cost of any additional diagnostic tests done by a participant
timeFrame: from day of admission to emergency department upto about 28 day follow up
measure: Cost of any additional consults done by a participant
timeFrame: from day of day of admission to emergency department upto about 28 day follow up
measure: Total cost of any antimicrobial treatments by a participant
timeFrame: end of study (about 28 days from baseline)
measure: Number of participants that were admitted to the hospital
timeFrame: end of study (about 28 days from baseline)
measure: Cost of hospital stay
timeFrame: end of study (about 28 days from baseline)
measure: Length of hospital stay
timeFrame: at time of discharge( from 28 days- 6months from baseline)
Secondary outcomes:
measure: Length of stay in emergency department
timeFrame: at time of discharge from emergency department (upto about 48 hours form admission)
measure: Number of participants that had a bounce back as defined as patients returning any time during the 28-day call back period
timeFrame: end of study (about 28 days from baseline)
measure: Emergency room work-up costs
timeFrame: at time of discharge from emergency department (upto about 48 hours form admission)
measure: Number of participants with medical interventions such as blood draws, consults and imaging used during the patient's time in the study
timeFrame: end of study (about 28 days from baseline)
measure: Quality of care as determined by the number of acute respiratory ill patients with bacterial etiology that received appropriate antibiotics
timeFrame: Within 1-3 hours of admission to emergency department
measure: Number of participants within the upper respiratory infection (URI) cohort without a bacterial source (viral, inflammatory, etc.) who appropriately did not receive antibiotics or whose antibiotic course was withheld during the patient's time in the study
timeFrame: end of study (about 28 days from baseline)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: David Robinson, MD,MS,MMM
role: PRINCIPAL_INVESTIGATOR
References: