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

ConditionRespiratory Tract Infections
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center, Houston

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: MeMed BV® biomarker test and standard of careExperimental treatment 2 interventions
Group B: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
from day of admission to emergency department upto about 28 day follow up
2

Cost of any additional consults done by a participant

Comparative metric between the experimental and control groups

Time frame
from day of day of admission to emergency department upto about 28 day follow up
3

Total cost of any antimicrobial treatments by a participant

Comparative metric between the experimental and control groups

Time frame
end of study (about 28 days from baseline)
4

Number of participants that were admitted to the hospital

Comparative metric between the experimental and control groups

Time frame
end of study (about 28 days from baseline)

Secondary outcomes

1

Length of stay in emergency department

Comparative metric between the experimental and control groups

Time frame
at time of discharge from emergency department (upto about 48 hours form admission)
2

Number of participants that had a bounce back as defined as patients returning any time during the 28-day call back period

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

Time frame
end of study (about 28 days from baseline)
3

Emergency room work-up costs

Comparative metric between the experimental and control groups

Time frame
at time of discharge from emergency department (upto about 48 hours form admission)
4

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

Time frame
end of study (about 28 days from baseline)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

MeMed Diagnostics Ltd.

Collaborator

Source ClinicalTrials.gov
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