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Yersinia Pestis Lateral Flow Immunoassay for Blood Samples

NCT ID: NCT04688996

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-19

Study Completion Date

2023-01-31

Brief Summary

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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.

Detailed Description

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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. These validation data will eventually be presented to US Food and Drug Administration (FDA; along with data from other studies that NAU will not participate) to seek approval for commercial license. The objective will be to validate this assay on the capillary blood of humans suspected to have plague as well as a study cohort likely to not have plague. From the suspected population; the specific aims of this study are to enroll up to 300 participants who present clinical signs of illness based on specific inclusion criteria. We will collect two types of blood samples from enrolled participants 1) capillary blood from a finger prick and 2) venous blood. The capillary blood will be used for direct testing on the LFI assay and the venous blood will be used to perform independent validations. This study is designed as a correlation study to understand 1) how LFI assay results compare with results from traditional diagnostic methods based on DNA detection methods and bacterial culture isolate on bubo aspirate or sputum and 2) effectiveness of capillary blood to serve as a diagnostic clinical sample as compared with traditional biological samples (venous blood, bubo and sputum). The study is designed to evaluate the outcome of LFI and how LFI results correlate with the standard plague diagnostics methods used in Madagascar and other methods. We are not examining the relationship between the results of the LFI and health outcomes of the participants. Decision of participant's medical treatment is solely based on the clinical judgment of the physician and guidelines set forth by Madagascar National Plague Control Program (PNLP); no formal test is involved with medical decision. All participants who are tested by LFI will have received medical treatment prior to the start of the study and the continuation of their medical treatment is guided by PNLP and physician judgment only. Again, we are not looking at the relationship between the results of the LFI and health outcomes of the participants.

From the non-suspect cohort, greater detail will be provided as obtained. In brief, this 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.

Conditions

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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

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Lateral Flow Assay for Pathogens of the Plague

Intervention Type 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).

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.

Lateral Flow Assay for Pathogens of the Plague

Intervention Type 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).

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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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

Eligibility Criteria

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Inclusion Criteria

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.


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

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)


1. \<13 y.o.
2. Unable to give written consent (if under 18)
Minimum Eligible Age

5 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northern Arizona University

OTHER

Sponsor Role collaborator

New Horizons Diagnostics Corporation

UNKNOWN

Sponsor Role collaborator

Institut Pasteur de Madagascar

OTHER

Sponsor Role collaborator

Naval Health Research Center

FED

Sponsor Role collaborator

Brimrose Technology Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dawn J Birdsell, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Northern Arizona University

David M Wagner, Ph.D.

Role: STUDY_DIRECTOR

Northern Arizona University

Minoarisoa Rajerison, Ph.D.

Role: STUDY_DIRECTOR

Institut Pasteur de Madagascar

Voahangy Andrianaivoarimanana, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur de Madagascar

Chris Myers, Ph.D.

Role: STUDY_DIRECTOR

Naval Health Research Center

Caroline Balagout

Role: PRINCIPAL_INVESTIGATOR

Naval Health Research Center

David P Trudil

Role: STUDY_CHAIR

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

Locations

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US Naval Health Research Center

San Diego, California, United States

Site Status RECRUITING

Institut Pasteur de Madagascar

Antananarivo, Analamanga Region, Madagascar

Site Status RECRUITING

Countries

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United States Madagascar

Central Contacts

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David P Trudil

Role: CONTACT

Phone: 410-499-7062

Email: [email protected]

Gregory R Siragusa, Ph.D.

Role: CONTACT

Phone: 262-309-5360

Email: [email protected]

Facility Contacts

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Christopher A Myers, Ph.D.

Role: primary

Caroline J Balagout

Role: backup

Voahangy Andrianaivoarimanana, Ph.D.

Role: primary

Minoarisoa RAJERISON, Ph.D>

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 10807389 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16841399 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12547544 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18198939 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24244760 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9302210 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Related Links

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http://www.pasteur.mg/

Institut Pasteur de Madagascar

https://in.nau.edu/pmi/

Northern Arizona Univerity Pathogen and Microbiome Institute

Other Identifiers

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Evaluation of diagnostic tools

Identifier Type: OTHER

Identifier Source: secondary_id

Plague Lateral Flow Assay

Identifier Type: -

Identifier Source: org_study_id

NCT04562012

Identifier Type: -

Identifier Source: nct_alias