Yersinia Pestis Lateral Flow Immunoassay for Blood Samples

NCT04688996 | Unknown FDA Device

• 2 other identifiers: Plague Lateral Flow AssayEvaluation of diagnostic tools
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 2

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; Yersinia Pestis; Pneumonia; Yersinia Sepsis; Yersinia Pestis Infection; Bubo; Yersinia Pestis; Bubonic; Plague, Skin; Pneumonic Plague

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

Outcome Measures

Primary Outcomes (1)

• LFI results on finger-prick blood correlate with the results of standard WHO-approved diagnostic tests for plague

  Description: Standard WHO-approved diagnostic testing uses bubo aspirates or sputum as clinical matrices to perform the following tests: F1RDT, qPCR analysis, and culture. WHO defines a confirmatory positive plague case when the bubo or sputum is positive on F1RDT and positive on either qPCR or culture.

  Up to 3 weeks post sample collection and processing of each participant.

Secondary Outcomes (1)

• LFI results on finger-prick blood correlate with LFI results from bubo aspirate or sputum clinical matrices.

  Up to 3 weeks post sample collection and processing of each participant.

Other Outcomes (1)

• LFI results on finger-prick blood correlate with the test results on venous blood using the following diagnostic methods: LFI, qPCR, ELISA and FilmArray Warrior Panel.

  Two years through sample collection and analysis completion from 05/2020 to 05/2022.

Study Arms (2)

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.

Diagnostic Test: Lateral Flow Assay for Pathogens of the Plague

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.

Diagnostic Test: Lateral Flow Assay for Pathogens of the Plague

Interventions

Lateral Flow Assay for Pathogens of the Plague DIAGNOSTIC_TEST

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).

Also known as: Lateral Flow Immunoassay for the Plague, SMART Plague Rapid Test, SMARTPRT, PRT, Plague LFI for F1 and LcrV antigens of Y. pestis, Lateral Flow Immunoassay for Yersinia pestis, LFI

Malagasy Participants; USN Health Research Center

Eligibility Criteria

• Age: 5 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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)
• \. 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).
• \<13 y.o.
• Unable to give written consent (if under 18)

Sponsors & Collaborators

• Brimrose Technology Corporation: lead
• Northern Arizona University: collaborator
• New Horizons Diagnostics Corporation: collaborator
• Institut Pasteur de Madagascar: collaborator
• Naval Health Research Center: collaborator

Study Sites (2)

US Naval Health Research Center

San Diego, California, 92101, United States

RECRUITING

Institut Pasteur de Madagascar

Antananarivo, Analamanga Region, 101, Madagascar

RECRUITING

Related Publications (6)

• Inglesby TV, Dennis DT, Henderson DA, Bartlett JG, Ascher MS, Eitzen E, Fine AD, Friedlander AM, Hauer J, Koerner JF, Layton M, McDade J, Osterholm MT, O'Toole T, Parker G, Perl TM, Russell PK, Schoch-Spana M, Tonat K. Plague as a biological weapon: medical and public health management. Working Group on Civilian Biodefense. JAMA. 2000 May 3;283(17):2281-90. doi: 10.1001/jama.283.17.2281.

  PMID: 10807389 BACKGROUND

• International meeting on preventing and controlling plague: the old calamity still has a future. Wkly Epidemiol Rec. 2006 Jul 14;81(28):278-84. No abstract available. English, French.

  PMID: 16841399 BACKGROUND

• Chanteau S, Rahalison L, Ralafiarisoa L, Foulon J, Ratsitorahina M, Ratsifasoamanana L, Carniel E, Nato F. Development and testing of a rapid diagnostic test for bubonic and pneumonic plague. Lancet. 2003 Jan 18;361(9353):211-6. doi: 10.1016/S0140-6736(03)12270-2.

  PMID: 12547544 BACKGROUND

• Stenseth NC, Atshabar BB, Begon M, Belmain SR, Bertherat E, Carniel E, Gage KL, Leirs H, Rahalison L. Plague: past, present, and future. PLoS Med. 2008 Jan 15;5(1):e3. doi: 10.1371/journal.pmed.0050003.

  PMID: 18198939 BACKGROUND

• Andrianaivoarimanana V, Kreppel K, Elissa N, Duplantier JM, Carniel E, Rajerison M, Jambou R. Understanding the persistence of plague foci in Madagascar. PLoS Negl Trop Dis. 2013 Nov 7;7(11):e2382. doi: 10.1371/journal.pntd.0002382. eCollection 2013 Nov.

  PMID: 24244760 BACKGROUND

• Rasoamanana B, Leroy F, Boisier P, Rasolomaharo M, Buchy P, Carniel E, Chanteau S. Field evaluation of an immunoglobulin G anti-F1 enzyme-linked immunosorbent assay for serodiagnosis of human plague in Madagascar. Clin Diagn Lab Immunol. 1997 Sep;4(5):587-91. doi: 10.1128/cdli.4.5.587-591.1997.

  PMID: 9302210 BACKGROUND

Related Links

• Institut Pasteur de Madagascar
• Northern Arizona Univerity Pathogen and Microbiome Institute

Biospecimen

Retention: SAMPLES WITH DNA

Capillary Blood, Sputum, Bubo Aspirates, Venous Blood

MeSH Terms

Conditions

Plague

Condition Hierarchy (Ancestors)

Yersinia Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vector Borne Diseases

Study Officials

• Dawn J Birdsell, Ph.D.

  Northern Arizona University

  PRINCIPAL INVESTIGATOR

• David M Wagner, Ph.D.

  Northern Arizona University

  STUDY DIRECTOR

• Minoarisoa Rajerison, Ph.D.

  Institut Pasteur de Madagascar

  STUDY DIRECTOR

• Voahangy Andrianaivoarimanana, Ph.D.

  Institut Pasteur de Madagascar

  PRINCIPAL INVESTIGATOR

• Chris Myers, Ph.D.

  Naval Health Research Center

  STUDY DIRECTOR

• Caroline Balagout

  Naval Health Research Center

  PRINCIPAL INVESTIGATOR

• David P Trudil

  New Horizons Diagnostics, Inc./Brimrose Biotechnology, Corp.

  STUDY CHAIR

Central Study Contacts

David P Trudil

CONTACT

410-499-7062; Davidt@nhdetect.com

Gregory R Siragusa, Ph.D.

CONTACT

262-309-5360; gsiragusa@nhdiag.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 30, 2020
• Study Start: October 19, 2020
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: December 14, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); MA (1)