Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-27 @ 4:05 PM
Study NCT ID:
NCT06379061
Status:
COMPLETED
Last Update Posted:
2025-06-05
First Post:
2024-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts
Sponsor:
Beckman Coulter, Inc.
Organization:
Study Overview
Official Title:
Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MMP-01-24 | OTHER | Beckman Coulter, Inc. | View |