Recruiting

Yersinia Pestis

Sponsor:

Brimrose Technology Corporation

Code:

NCT04688996

Conditions

Plague

Plague, Bubonic

Plague, Pneumonic

Yersinia Pestis Plague

Yersinia Pestis; Bubo

Eligibility Criteria

Sex: All

Age: 5 - 70+

Healthy Volunteers: Not accepted

Interventions

Lateral Flow Assay for Pathogens of the Plague

Study Details

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 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

Study ID

NCT04688996

Start date

Oct 19, 2020

Status verified date

Aug, 2022

Completion date

Jan, 2023

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Malagasy Participants

Malagasy Participants. Subjects will be recruited at rural health centers throughout Madagascar. Participants will be comprised of rural people with symptoms consistent with plague. The Madagascar Ministry of Public Health requires declaration of all suspected human plague cases and collection of biological samples (sputum and/or bubo aspirates) from these cases for medical workup for confirmation.

USN Health Research Center

USN Health Center Participants. The subject population will consist of active duty US Naval personnel and DoD beneficiaries presenting to participating study sites in the United States with influenza-like symptoms (fever, cough, sore throat). Since the US is non-endemic for plague, all participants will be presumed to be negative for Y. pestis.

Interventions

Lateral Flow Assay for Pathogens of the Plague

A dipstick type of rapid test for antigens of the plague bacterium Yersinia pestis in samples from enrolled participants from both a known geography of plague activity (Madagascar) as well as samples from a geographically separated population of likely plague free status (US Naval Health Research Center, San Diego, CA).

Primary outcome measure

  • LFI results on finger-prick blood correlate with the results of standard WHO-approved diagnostic tests for plague [ Time Frame: Up to 3 weeks post sample collection and processing of each participant. ]

Central Contacts and Locations

Central contacts

David P Trudil

410-499-7062Davidt@nhdetect.com

Gregory R Siragusa, Ph.D.

262-309-5360gsiragusa@nhdiag.com

Locations

US Naval Health Research Center

Recruiting

San Diego, California, United States, 92101

Contacts

Christopher A Myers, Ph.D.

619-756-8483christopher.a.meyers48.civ@mail.mil

Caroline J Balagout

619-553-8950caroline.j.balagot.ctr@mail.mil

More Information

Sponsor

Brimrose Technology Corporation

Last update posted

Dec 14, 2022

Last verified

Aug, 2022

Keywords

  • Yersinia pestis Lateral Flow Device
  • Lateral Flow Device
  • Point of Care testing, plague
  • Point of Need testing, plague
  • Plague
  • Yersinia pestis
  • Yersinia pestis antigens
  • Yersinia pestis LcrV antigen
  • Plague rapid test
  • Yersinia rapid test
  • Bubonic plague
  • Sputum
  • Bubo aspirate
  • Pneumonic plague
  • Yersinia pestis ELISA
  • Yersinia pestis EIA
  • Black plague
  • Black death
  • Yersinia LcrV protein
  • Yersinia F1 antigen
  • Yersinia PCR
  • Lateral Flow Immunoassays

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brimrose Technology Corporation on 2022-12-14.