Status:
UNKNOWN
Yersinia Pestis Lateral Flow Immunoassay for Blood Samples
Lead Sponsor:
Brimrose Technology Corporation
Collaborating Sponsors:
Northern Arizona University
New Horizons Diagnostics Corporation
Conditions:
Plague
Plague, Bubonic
Eligibility:
All Genders
5-75 years
Brief Summary
Plague is a deadly but highly treatable disease caused by the bacterium Y. pestis. Due to the historical development of Y. pestis as a bioweapon by several nation states, it is listed by the US as a p...
Detailed Description
The purpose of this study will be to generate the data required to thoroughly validate the ability of plague LFI assay (Lateral Flow Immunoassay) to accurately diagnose human infections with Y. pestis...
Eligibility Criteria
Inclusion
- Inclusion criteria - Malagasy Participants
- Adults 18 to 75 years old (male and female): Able to receive and give verbal communication.
- Children 5 to 17 years old (vulnerable population): Parents or legal guardian must be available to give permission. Parents or legal guardian to consent for children (5-6 years).
- Suspected human plague case by local medical professional. Include at least one of the following: For bubonic plague: high fever, chills, and/or presence of painful bubo; For pneumonic plague: high fever, chills, cough for less than 5 days, bloody sputum, and/or chest pains; patients may be recruited from both plague surveillance program and non-plague surveillance programs.
- Exclusion criteria - Malagasy Participants
- Children under the age of 5 years old
- Children between the age of 5 years to 17 years without a parent or legal guardian
- Not compliant with the study procedure (blood sampling)
- Inclusion criteria - USN Health Center Participants
- Active duty personnel and DoD beneficiaries that present to participating study sites with influenza-like-illness (fever, cough, sore throat).
- Age range \>=13 to 75 y.o.
- Able to receive/give consent (or assent if \<18 y.o.) 4, Presenting with influenza-like-illness (fever of 100.5 F or higher, cough and/or sore throat)
- 5\. USN Special Categories: Minors/children (45CFR Subpt. D/DoDI 3216.02, Encl 3, Para 7d); Students; Active duty military personnel (3216.02, Encl.3 Para. 7.e); Economically disadvantaged persons (32CFR 219.11(b); Educationally disadvantaged persons (32CFR 219.11(b).
- Exclusion criteria - USN Health Center Participants
- \<13 y.o.
- Unable to give written consent (if under 18)
Exclusion
Key Trial Info
Start Date :
October 19 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04688996
Start Date
October 19 2020
End Date
January 1 2023
Last Update
December 14 2022
Active Locations (2)
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1
US Naval Health Research Center
San Diego, California, United States, 92101
2
Institut Pasteur de Madagascar
Antananarivo, Analamanga Region, Madagascar, 101