Evaluation of the SRI B. Anthracis Lethal Factor Diagnostic System
NCT ID: NCT05672875
Last Updated: 2023-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
343 participants
OBSERVATIONAL
2023-01-23
2023-04-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy and Symptomatic Subjects
Blood sample testing on the Anthrax LF Dx System
Anthrax LF Dx System
Lateral flow immunoassay for the detection of the LF biomarker in whole blood samples.
Interventions
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Anthrax LF Dx System
Lateral flow immunoassay for the detection of the LF biomarker in whole blood samples.
Eligibility Criteria
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Inclusion Criteria
* Subject is willing and able to provide Informed Consent for study participation, prior to any study mandated procedures
* For the healthy human population: Subject is in general good health with a stable health status based on medical history, and the investigator's clinical judgment defined as:
* No acute medical conditions that require the use of systemic prescription medications in the last 30 days and
* Any chronic medical diagnoses/conditions should be stable for the last 30 days (no hospitalizations, emergency room (ER), or urgent care for condition). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis/condition in the 30 days before enrollment.
* For the symptomatic human population:
* Current symptoms consistent with cold, flu or other bronchial and symptomatic infections. The subject must currently (day of consent) have at least one of the following symptoms: fever, chills, chest discomfort, shortness of breath, cough, dizziness/confusion, nausea, headache, sweats, fatigue, or body aches.
Exclusion Criteria
* Subject has previously enrolled in this study, or subject has previously failed screening for this study.
* Subject has any medical or social or psychiatric condition(s) or current substance abuse that, in the opinion of the investigator, would preclude the subject's ability to provide informed consent/assent, or to comply with the study requirements.
* Currently enrolled in an investigational drug or device clinical study in which the primary endpoint has not occurred or occurred within the last 30 days.
* Subject is a nursing home resident.
* Subject is a prisoner.
18 Years
ALL
Yes
Sponsors
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Department of Health and Human Services
FED
SRI International
INDUSTRY
Responsible Party
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Locations
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WellNow Urgent Care and Research
Cincinnati, Ohio, United States
WellNow Urgent Care and Research
Columbus, Ohio, United States
WellNow Urgent Care and Research
Dayton, Ohio, United States
Countries
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Other Identifiers
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4650.367
Identifier Type: -
Identifier Source: org_study_id