Viewing Study NCT05672875



Ignite Creation Date: 2024-05-06 @ 6:28 PM
Last Modification Date: 2024-10-26 @ 2:48 PM
Study NCT ID: NCT05672875
Status: TERMINATED
Last Update Posted: 2023-11-30
First Post: 2023-01-03

Brief Title: Evaluation of the SRI B Anthracis Lethal Factor Diagnostic System
Sponsor: SRI International
Organization: SRI International

Study Overview

Official Title: Clinical Specificity Evaluation of the SRI B Anthracis Lethal Factor Diagnostic System
Status: TERMINATED
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Sponsor decision
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study is intended to estimate the Anthrax LF Dx System specificity Sensitivity will be estimated with 10 of the samples spiked with recombinant Bacillus anthracis lethal factor LF used to prepare contrived positive samples
Detailed Description: This is a prospective non-interventional multi-center study assessing the clinical specificity of the Anthrax LF Dx System using venous blood samples collected from presumptive anthrax negative adult male and female healthy and symptomatic subjects non- B anthracis infected

Up to 500 subjects may be enrolled to meet the goal of 440 evaluable subjects 220 healthy and 220 symptomatic Subjects will have one venous blood sample collected from a single time-point tested with the Anthrax LF Dx System At each clinical site specimens will be randomly selected such that 10 40 of 400 of all subjects venous blood samples total of 40 20 healthy and 20 symptomatic will be spiked with recombinant B anthracis LF to prepare a contrived positive sample An unblinded operator will prepare the spiked samples and provide both the spiked and neat samples to a blinded operator for testing on the Anthrax LF Dx System Thus the blinded operator will receive samples that could either be spiked positive or neat presumed negative to preserve the blind

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: True
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None