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The purpose of the pivotal study is to collect blood specimens and clinical data from pediatric (\>90 days old) and adult (≥18 years old) patients presenting with signs and symptoms suggestive of acute bacterial or viral infection. These samples will be used to establish the diagnostic performance of MeMed BV™ for differentiating bacterial from viral infection using method comparison and/or method concordance.
The objective of this study is to collect blood specimens from pediatric (\>90 days old) and adult patients (≥18 years old) presenting with signs and symptoms suggestive of acute bacterial or viral infection from hospital, Emergency Department, or Urgent Care Centers for comparative testing on the Access 2 and DxI 9000 Immunoassay Analyzers.
Age
0 - 89 years
Sex
ALL
Healthy Volunteers
No
Indiana University School of Medicine
Indianapolis, Indiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Brigham
Boston, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
Start Date
June 12, 2024
Primary Completion Date
January 31, 2025
Completion Date
April 30, 2025
Last Updated
June 5, 2025
650
ACTUAL participants
Adult and Pediatrics
OTHER
Lead Sponsor
Beckman Coulter, Inc.
Collaborators
NCT05993442
NCT04436991
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06018792