Yersinia Pestis Lateral Flow Immunoassay for Blood Samples
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.
Conditions:
🦠 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
🗓️ Study Start (Actual) 19 October 2020
🗓️ Primary Completion (Estimated) December 2022
✅ Study Completion (Estimated) January 2023
👥 Enrollment (Estimated) 500
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 San Diego, California, United States
📍 Antananarivo, Analamanga, Madagascar

📋 Eligibility Criteria

Description

  • Inclusion criteria - Malagasy Participants
  • 1. Adults 18 to 75 years old (male and female): Able to receive and give verbal communication.
  • 2. 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).
  • 3. 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
  • 1. Children under the age of 5 years old
  • 2. Children between the age of 5 years to 17 years without a parent or legal guardian
  • 3. Not compliant with the study procedure (blood sampling)
  • Inclusion criteria - USN Health Center Participants
  • 1. Active duty personnel and DoD beneficiaries that present to participating study sites with influenza-like-illness (fever, cough, sore throat).
  • 2. Age range \>=13 to 75 y.o.
  • 3. 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
  • 1. \<13 y.o.
  • 2. Unable to give written consent (if under 18)
Ages Eligible for Study: 5 Years to 75 Years (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 November 2020
  • First Submitted that Met QC Criteria 28 December 2020
  • First Posted 30 December 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 December 2022
  • Last Update Posted 14 December 2022
  • Last Verified August 2022