Respiratory InfectionNCT05706935
MeMed BV® Test Evaluation in Adult Emergency Department Patients
An observational study of Respiratory Infection and Respiratory Infections in Old Age, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The goal of this observational study is to compare the results of a serum biomarker called the MeMed BV®, which is approved to help differentiate between bacterial and viral respiratory infections, to clinical diagnoses of adult emergency department patients presenting with recent fever and signs or symptoms of a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Infection, Respiratory Infections in Old Age, Respiratory Infection Virus
- What is being tested?
- MeMed BV® test
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2023to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults presenting to the ED with history of recent fever and signs or symptoms of acute respiratory infection.
Who may be able to join
- Adults presenting to the emergency department
- Subjective or objective fever within the past 7 days
- Signs or symptoms of upper or lower respiratory tract infection within the past 7 days
Who cannot join
- Prisoner
- Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis
- Active inflammatory disease
- Congenital or acquired immune deficiency
- Chronic fungal or parasitic infection
- Infection with human immunodeficiency virus (HIV)
Show all 13Show fewer
- Hepatitis B virus (HBV)
- Hepatitis C virus (HCV)
- Infection with active tuberculosis (TB)
- Significant trauma or burns in the last 7 days
- Patients that have undergone major surgery in the last 7 days
- Pregnancy
- Active malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the MeMed BV® Test in Adult Emergency Department Patients With Fever and Acute Respiratory Symptoms
The goal of this observational study is to compare the results of a serum biomarker called the MeMed BV®, which is approved to help differentiate between bacterial and viral respiratory infections, to clinical diagnoses of adult emergency department patients presenting with recent fever and signs or symptoms of a respiratory infection. Active participation is completed during the emergency department visit and includes drawing blood, obtaining a sputum sample, and answering survey questions.
Read the detailed description
The MeMed BV® is a diagnostic test newly approved by the FDA to assess the likelihood of bacterial vs. viral respiratory infections based on protein biomarkers in blood. This study aims to identify the level of agreement between the results of the MeMed BV® (bacterial/viral) and the standard of care treatment received by the participant (e.g. antibiotics for patient diagnosed with bacterial pneumonia) in order to see if implementing the MeMed BV® into standard clinical care would potentially change diagnosis.
- Conditions
- Respiratory Infection, Respiratory Infections in Old Age, Respiratory Infection Virus, Respiratory Infection Bacterial
- Being tested
- MeMed BV® test
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeMed BV® testDiagnostic test
The MeMed BV® test is an automated semiquantitative immunoassay that measures three nonmicrobial (host) proteins (TRAIL, IP-10, and CRP) in serum samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection.
What is being measured
The primary outcome is the main question the study is designed to answer.
MeMed BV® test result and diagnostic concordance
Percent agreement between result of MeMed BV® test (bacterial or viral respiratory infection) and antibiotic prescribing by emergency medicine doctor (which implies suspected bacterial infection)
Measured: Emergency department 1 day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start6 Feb 2023
- Primary completion31 Jul 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Pulia, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706935
- Sponsor's protocol ID
- 2022-1612
- Other IDs
- SMPH/EMERG MED, Protocol Version 1/13/2023
- Status last verified
- Jan 2024
- First submitted
- 20 Jan 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the MeMed BV® Test in Adult Emergency Department Patients With Fever and Acute Respiratory Symptoms
- ClinicalTrials.gov ID
- NCT05706935
- Acronym / sponsor ID
- 2022-1612
- Conditions
- Respiratory Infection, Respiratory Infections in Old Age, Respiratory Infection Virus, Respiratory Infection Bacterial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to compare the results of a serum biomarker called the MeMed BV®, which is approved to help differentiate between bacterial and viral respiratory infections, to clinical diagnoses of adult emergency department patients presenting with recent fever and signs or symptoms of a respiratory infection. Active participation is completed during the emergency department visit and includes drawing blood, obtaining a sputum sample, and answering survey questions.
Detailed description
The MeMed BV® is a diagnostic test newly approved by the FDA to assess the likelihood of bacterial vs. viral respiratory infections based on protein biomarkers in blood. This study aims to identify the level of agreement between the results of the MeMed BV® (bacterial/viral) and the standard of care treatment received by the participant (e.g. antibiotics for patient diagnosed with bacterial pneumonia) in order to see if implementing the MeMed BV® into standard clinical care would potentially change diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults presenting to the ED with history of recent fever and signs or symptoms of acute respiratory infection.
Key inclusion criteria (3 listed)
- Adults presenting to the emergency department
- Subjective or objective fever within the past 7 days
- Signs or symptoms of upper or lower respiratory tract infection within the past 7 days
Key exclusion criteria (13 listed)
- Prisoner
- Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis
- Active inflammatory disease
- Congenital or acquired immune deficiency
- Chronic fungal or parasitic infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeMed BV® testThe MeMed BV® test is an automated semiquantitative immunoassay that measures three nonmicrobial (host) proteins (TRAIL, IP-10, and CRP) in serum samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. | Diagnostic test | – |
Primary outcome
MeMed BV® test result and diagnostic concordance
Time frame: Emergency department 1 day visit
Percent agreement between result of MeMed BV® test (bacterial or viral respiratory infection) and antibiotic prescribing by emergency medicine doctor (which implies suspected bacterial infection)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Pulia, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Infection and Respiratory Infections in Old Age, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MeMed BV® test result and diagnostic concordance (time frame: Emergency department 1 day visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.