Yersinia Pestis Lateral Flow Immunoassay for Blood Samples
Status unconfirmed
Conditions studied: Plague, Plague, Bubonic, Plague, Pneumonic, Yersinia Pestis Plague, Yersinia Pestis; Bubo, Yersinia Pestis; Pneumonia, Yersinia Sepsis, Yersinia Pestis Infection, Bubo; Yersinia Pestis, Bubonic; Plague, Skin, Pneumonic Plague
In brief
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 potential bioweapon that could be used against US warfighters. Although this bacterium is ecologically established worldwide, it mostly affects impoverished people who live in rural low-resource areas of Madagascar. Plague is acquired directly from bites of infected fleas but, if left untreated, it can progress to the highly lethal pneumonic form that can result in human to human transmission. With the dangers of pneumonic plague in the context of both natural outbreak and as a bioweapon used against warfighter, the goal of this study is to investigate a diagnostic test that is able to rapidly and locally diagnose this disease in low-resource settings. This study aims to evaluate a US-developed new LFI (Lateral Flow Immunoassay) assay intended for capillary blood (finger-prick) to diagnose humans infected with Y. pestis. The investigators will rigorously validate with assay on human populations from active plague sites and correlate the results with the results of paired clinical samples used in standard medical workup using existing diagnostics tests.
Key facts
- Study ID
- NCT04688996
- Run by
- Brimrose Technology Corporation
- People needed
- 500
- Starts
- 2020-10-19
- Expected to finish
- 2023-01-01
- Last updated by the study team
- 2022-12-14
Who can join
Age: 5 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- US Naval Health Research Center — San Diego, California, United States (enrolling)
- Institut Pasteur de Madagascar — Antananarivo, Analamanga Region, Madagascar (enrolling)
Full record on ClinicalTrials.gov
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