Status:
COMPLETED
Evaluation of the Clinical Specificity of the Active Anthrax Detect™ Plus (AAD Plus) Lateral Flow Immunoassay (LFI)
Lead Sponsor:
InBios International, Inc.
Collaborating Sponsors:
Fast-Track Drugs & Biologics, LLC
Biomedical Advanced Research and Development Authority
Conditions:
Anthrax
Eligibility:
All Genders
18-90 years
Brief Summary
The primary objective of the study is to determine the estimated clinical specificity of the AAD Plus. A secondary objective is to determine the estimated sensitivity of the AAD Plus as 10% of the stu...
Detailed Description
This study is a multi-site trial assessing the clinical specificity of AAD Plus using capillary blood, venous blood, and venous serum samples collected from presumptive anthrax negative subjects who p...
Eligibility Criteria
Inclusion
- Male or female, 18 to 90 years of age.
- Current symptoms consistent with cold, flu or other bronchial and febrile 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
- Nursing home residents
- Inmates/subjects in police custody
- Unable to understand verbal or written language of the consent or require a Legal Authorized Representative for consent
Key Trial Info
Start Date :
March 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 17 2020
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04320485
Start Date
March 25 2020
End Date
December 17 2020
Last Update
February 10 2021
Active Locations (4)
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1
Fiel Family and Sports Medicine/CCT Research
Tempe, Arizona, United States, 85283
2
Hometown Urgent Care and Research
Cincinnati, Ohio, United States, 45215
3
Hometown Urgent Care and Research
Columbus, Ohio, United States, 43214
4
Hometown Urgent Care and Research
Dayton, Ohio, United States, 45424