Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-28 @ 3:59 PM
Study NCT ID:
NCT05706935
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2023-01-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MeMed BV® Test Evaluation in Adult Emergency Department Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-17', 'size': 185198, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-08-29T10:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Saliva and mouth swabs, blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2023-01-20', 'studyFirstSubmitQcDate': '2023-01-30', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MeMed BV® test result and diagnostic concordance', 'timeFrame': 'Emergency department 1 day visit', 'description': '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)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Respiratory Infection', 'Respiratory Infections in Old Age', 'Respiratory Infection Virus', 'Respiratory Infection Bacterial']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults presenting to the ED with history of recent fever and signs or symptoms of acute respiratory infection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults presenting to the emergency department\n* Subjective or objective fever within the past 7 days\n* Signs or symptoms of upper or lower respiratory tract infection within the past 7 days\n\nExclusion Criteria:\n\n* Prisoner\n* Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis\n* Active inflammatory disease\n* Congenital or acquired immune deficiency\n* Chronic fungal or parasitic infection\n* Infection with human immunodeficiency virus (HIV)\n* Hepatitis B virus (HBV)\n* Hepatitis C virus (HCV)\n* Infection with active tuberculosis (TB)\n* Significant trauma or burns in the last 7 days\n* Patients that have undergone major surgery in the last 7 days\n* Pregnancy\n* Active malignancy'}, 'identificationModule': {'nctId': 'NCT05706935', 'briefTitle': 'MeMed BV® Test Evaluation in Adult Emergency Department Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Evaluation of the MeMed BV® Test in Adult Emergency Department Patients With Fever and Acute Respiratory Symptoms', 'orgStudyIdInfo': {'id': '2022-1612'}, 'secondaryIdInfos': [{'id': 'SMPH/EMERG MED', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 1/13/2023', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MeMed BV® test', 'type': 'DIAGNOSTIC_TEST', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Michael Pulia, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}