Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| MeMed Diagnostics Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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)
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MeMed BV® biomarker test and standard of care | Experimental | In addition to the standard of care for acute respiratory infections, the experimental arm shall reveal the results of the 'BV' test to the clinician co-investigators. The BV test reports a clinical score from 1-100 that as an adjunct to usual care, may help the clinician better direct appropriate resources towards the patient. |
|
| Usual Care | Active Comparator | The co-investigators shall evaluate, diagnose and manage the acute respiratory infection presenting to the ED using the standard practice known in the community. This may include hospital sepsis practice protocols, clinical judgement, and national or local practice standards. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MeMed BV® biomarker test | Diagnostic Test | one purple top tube of whole blood (2-3 cc) to be used for the MeMed Key® device processing without the need for centrifuge. The MeMed BV® test takes approximately 15 minutes to process and result. After, the sample has been processed and the MeMed BV® test has resulted, the sample of blood will be discarded for each patient enrolled in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Cost of any additional diagnostic tests done by a participant | Additional diagnostic tests may include serial complete blood count (CBC)s, additional blood cultures, viral cultures and serial basic metabolic panel (BMP) blood bank | from day of admission to emergency department upto about 28 day follow up |
| Cost of any additional consults done by a participant | Comparative metric between the experimental and control groups | from day of day of admission to emergency department upto about 28 day follow up |
| Total cost of any antimicrobial treatments by a participant | Comparative metric between the experimental and control groups | end of study (about 28 days from baseline) |
| Number of participants that were admitted to the hospital | Comparative metric between the experimental and control groups | end of study (about 28 days from baseline) |
| Cost of hospital stay | Total costs defined as all costs including lab and diagnostic services, blood bank, pharmaceuticals, nursing, consultants, and all other services listed in the patient's work-up. Comparative metric between the experimental and control groups | end of study (about 28 days from baseline) |
| Length of hospital stay | Comparative metric between the experimental and control groups | at time of discharge( from 28 days- 6months from baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay in emergency department | Comparative metric between the experimental and control groups | at time of discharge from emergency department (upto about 48 hours form admission) |
| Number of participants that had a bounce back as defined as patients returning any time during the 28-day call back period |
Not provided
Inclusion Criteria for main study population :
Exclusion Criteria for main study population:
Inclusion Criteria for Subgroup:
Patients fulfilling one or more of the following exclusion criteria from the main group are eligible for the subgroup cohort:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Robinson, MD,MS,MMM | Contact | (713) 500-7873 | David.J.Robinson@uth.tmc.edu | |
| Neomi Sepulveda | Contact | 713.500.8474 | Neomi.Sepulveda@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| David Robinson, MD,MS,MMM | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Statistician assessing financial and resource utilization between study arms (primary and secondary outcomes) will be blinded as to which cohort had the results of the Memed diagnostic test (experimental vs standard groups)
|
| Usual care | Diagnostic Test | Usual care includes diagnostic hematology, chemistry, biomarkers, and culture results along with imaging, consults, and medications, in the treatment of acute viral and/or bacterial illness. |
|
Bounce backs are defined as any return to a health care entity during the 28 day period after discharge from the index visit. Comparative metric between the experimental and control groups |
| end of study (about 28 days from baseline) |
| Emergency room work-up costs | Comparative metric between the experimental and control groups | at time of discharge from emergency department (upto about 48 hours form admission) |
| Number of participants with medical interventions such as blood draws, consults and imaging used during the patient's time in the study | Comparative metric between the experimental and control groups | end of study (about 28 days from baseline) |
| Quality of care as determined by the number of acute respiratory ill patients with bacterial etiology that received appropriate antibiotics | Comparative metric between the experimental and control groups | Within 1-3 hours of admission to emergency department |
| 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 | Comparative metric between the experimental and control groups | end of study (about 28 days from baseline) |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D001424 | Bacterial Infections |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided