PlagueSMARTPRTNCT04688996
Yersinia Pestis Lateral Flow Immunoassay for Blood Samples
An observational study of Plague and Plague, Bubonic, run by Brimrose Technology Corporation at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 75 years
- Conditions the study is for
- Plague, Plague, Bubonic, Plague, Pneumonic
- What is being tested?
- Lateral Flow Assay for Pathogens of the Plague
- How many people
- 500 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 19 Oct 2020to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
- 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)
- 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).
Who cannot join
- 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)
- <13 y.o.
- Unable to give written consent (if under 18)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
US Naval Health Research Center
San Diego, California, 92101
Christopher A Myers, Ph.D., 619-756-8483, christopher.a.meyers48.civ@mail.mil
Caroline J Balagout, 619-553-8950, caroline.j.balagot.ctr@mail.mil
Madagascar1 site, 1 recruiting
- Recruiting
Institut Pasteur de Madagascar
Antananarivo, Analamanga Region, 101
Voahangy Andrianaivoarimanana, Ph.D., 00261340654145, kekely@pasteur.mg
Minoarisoa RAJERISON, Ph.D>, 00261341983916, mino@pasteur.mg
About this study
Official title: Point of Care Diagnostic to Identify the Causative Agent of the Plague in 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.
Read the detailed description
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
- Plague, Plague, Bubonic, Plague, Pneumonic, Yersinia Pestis Plague, Yersinia Pestis; Bubo, Yersinia Pestis; Pneumonia
- Being tested
- Lateral Flow Assay for Pathogens of the 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
- Medical subject headings
- Plague
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Flow Assay for Pathogens of the PlagueDiagnostic test
Also called Lateral Flow Immunoassay for the Plague, SMART Plague Rapid Test, SMARTPRT, PRT
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Lateral Flow Assay for Pathogens of the Plague |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Up to 3 weeks post sample collection and processing of each participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start19 Oct 2020
- Primary completionDec 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PlagueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brimrose Technology Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northern Arizona University, New Horizons Diagnostics Corporation, Institut Pasteur de Madagascar, Naval Health Research Center
- Responsible party
- Sponsor
- Investigators
- Dawn J Birdsell, Ph.D., Principal investigator, Northern Arizona UniversityDavid M Wagner, Ph.D., Study director, Northern Arizona UniversityMinoarisoa Rajerison, Ph.D., Study director, Institut Pasteur de MadagascarVoahangy Andrianaivoarimanana, Ph.D., Principal investigator, Institut Pasteur de MadagascarChris Myers, Ph.D., Study director, Naval Health Research CenterCaroline Balagout, Principal investigator, Naval Health Research CenterDavid P Trudil, Study chair, New Horizons Diagnostics, Inc./Brimrose Biotechnology, Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688996
- Sponsor's protocol ID
- Plague Lateral Flow Assay
- Other IDs
- Evaluation of diagnostic tools
- Acronym
- SMARTPRT
- Status last verified
- Aug 2022
- First submitted
- 24 Nov 2020
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 10807389International 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.
PubMed 16841399Chanteau 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.
PubMed 12547544Stenseth 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.
PubMed 18198939Andrianaivoarimanana 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.
PubMed 24244760Rasoamanana 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.
PubMed 9302210
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Diagnostic to Identify the Causative Agent of the Plague in Blood Samples
- ClinicalTrials.gov ID
- NCT04688996
- Acronym / sponsor ID
- SMARTPRT / Plague Lateral Flow Assay
- Conditions
- Plague, Plague, Bubonic, Plague, Pneumonic, Yersinia Pestis Plague, Yersinia Pestis; Bubo, Yersinia Pestis; Pneumonia
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Brimrose Technology CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Northern Arizona University, New Horizons Diagnostics Corporation, Institut Pasteur de Madagascar, Naval Health Research Center
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malagasy Participants | – | Diagnostic Test: Lateral Flow Assay for Pathogens of the PlagueMalagasy 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 | – | Diagnostic Test: Lateral Flow Assay for Pathogens of the PlagueUSN 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. |
Who may qualify
- Ages
- 5 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
- 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.
Key exclusion criteria (5 listed)
- 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)
- <13 y.o.
- Unable to give written consent (if under 18)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lateral Flow Assay for Pathogens of the PlagueAlso: Lateral Flow Immunoassay for the Plague, SMART Plague Rapid Test, SMARTPRT, PRTA 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). | Diagnostic test | Malagasy Participants, USN Health Research Center |
Primary outcome
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.
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.
1 secondary outcome
LFI results on finger-prick blood correlate with LFI results from bubo aspirate or sputum clinical matrices.
Time frame: Up to 3 weeks post sample collection and processing of each participant.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Background: PubMed 10807389Inglesby 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.
- Background: PubMed 16841399International 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.
- Background: PubMed 12547544Chanteau 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.
- Background: PubMed 18198939Stenseth 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.
- Background: PubMed 24244760Andrianaivoarimanana 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.
- Background: PubMed 9302210Rasoamanana 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.
- Institut Pasteur de MadagascarLink provided by the sponsor.
- Northern Arizona Univerity Pathogen and Microbiome InstituteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn J Birdsell, Ph.D. principal investigator
Northern Arizona University
David M Wagner, Ph.D. study director
Northern Arizona University
Minoarisoa Rajerison, Ph.D. study director
Institut Pasteur de Madagascar
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plague and Plague, Bubonic, run by Brimrose Technology Corporation at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Madagascar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David P Trudil (410-499-7062, Davidt@nhdetect.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04688996, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.