AnthraxNCT05672875
Evaluation of the SRI B. Anthracis Lethal Factor Diagnostic System
An observational study of Anthrax, run by SRI International at 3 sites in United States.
Trial summary
This study is intended to estimate the Anthrax LF Dx System specificity. Sensitivity will be estimated with 10% of the samples spiked with recombinant Bacillus anthracis lethal factor (LF) used to prepare contrived positive samples. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anthrax
- What is being tested?
- Anthrax LF Dx System
- How many people
- 343 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Jan 2023to 20 Apr 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult male and female healthy and symptomatic subjects.
Who may be able to join
- Male or female subject who is ≥18 years of age
- Subject is willing and able to provide Informed Consent for study participation, prior to any study mandated procedures
- For the healthy human population: Subject is in general good health with a stable health status based on medical history, and the investigator's clinical judgment defined as:
- No acute medical conditions that require the use of systemic prescription medications in the last 30 days and
- Any chronic medical diagnoses/conditions should be stable for the last 30 days (no hospitalizations, emergency room (ER), or urgent care for condition). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis/condition in the 30 days before enrollment.
- For the symptomatic human population:
- Current symptoms consistent with cold, flu or other bronchial and symptomatic infections. The subject must currently (day of consent) have at least one of the following symptoms: fever, chills, chest discomfort, shortness of breath, cough, dizziness/confusion, nausea, headache, sweats, fatigue, or body aches.
Who cannot join
- Subject has inclusion symptoms and tests positive for COVID-19.
- Subject has previously enrolled in this study, or subject has previously failed screening for this study.
- Subject has any medical or social or psychiatric condition(s) or current substance abuse that, in the opinion of the investigator, would preclude the subject's ability to provide informed consent/assent, or to comply with the study requirements.
- Currently enrolled in an investigational drug or device clinical study in which the primary endpoint has not occurred or occurred within the last 30 days.
- Subject is a nursing home resident.
- Subject is a prisoner.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
WellNow Urgent Care and Research
Cincinnati, Ohio, 45215
WellNow Urgent Care and Research
Columbus, Ohio, 43214
WellNow Urgent Care and Research
Dayton, Ohio, 45373
About this study
Official title: Clinical Specificity Evaluation of the SRI B. Anthracis Lethal Factor Diagnostic System
This study is intended to estimate the Anthrax LF Dx System specificity. Sensitivity will be estimated with 10% of the samples spiked with recombinant Bacillus anthracis lethal factor (LF) used to prepare contrived positive samples.
Read the detailed description
This is a prospective, non-interventional, multi-center study assessing the clinical specificity of the Anthrax LF Dx System using venous blood samples collected from presumptive anthrax negative adult male and female healthy and symptomatic subjects (non- B. anthracis infected).
Up to 500 subjects may be enrolled to meet the goal of 440 evaluable subjects (220 healthy and 220 symptomatic). Subjects will have one venous blood sample collected from a single time-point tested with the Anthrax LF Dx System. At each clinical site, specimens will be randomly selected such that 10% (40 of 400) of all subjects' venous blood samples (total of 40 [20 healthy and 20 symptomatic]) will be spiked with recombinant B. anthracis LF to prepare a contrived positive sample. An unblinded operator will prepare the spiked samples and provide both the spiked and neat samples to a blinded operator for testing on the Anthrax LF Dx System. Thus, the blinded operator will receive samples that could either be spiked (positive) or neat (presumed negative) to preserve the blind.
- Conditions
- Anthrax
- Being tested
- Anthrax LF Dx System
- Medical subject headings
- Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthrax LF Dx SystemDiagnostic test
Lateral flow immunoassay for the detection of the LF biomarker in whole blood samples.
| Study group | Role | What they receive |
|---|---|---|
| Healthy and Symptomatic Subjects | Blood sample testing on the Anthrax LF Dx System Receives: Diagnostic Test: Anthrax LF Dx System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The estimated negative percent agreement (NPA) of the Anthrax LF Dx System test.
The estimated NPA will be calculated from testing neat specimens from 400 subjects (with presumed negative samples).
Measured: Day of enrollment
Adverse events
All adverse events directly related to specimen collection will be reported.
Measured: Within 24 hours of blood draw
Secondary outcomes (1)
The estimated percent positive agreement (PPA) of the Anthrax LF Dx System test.
PPA will be estimated with samples spiked with recombinant B. anthracis lethal factor (LF) used to prepare contrived positive samples.
Measured: Day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start23 Jan 2023
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnthraxStudies 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
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- SRI International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672875
- Sponsor's protocol ID
- 4650.367
- Status last verified
- Nov 2023
- First submitted
- 3 Jan 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Specificity Evaluation of the SRI B. Anthracis Lethal Factor Diagnostic System
- ClinicalTrials.gov ID
- NCT05672875
- Acronym / sponsor ID
- 4650.367
- Conditions
- Anthrax
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 343 participants (actual)
- Lead sponsor
- SRI InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 5 Jan 2023 (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.
This study is intended to estimate the Anthrax LF Dx System specificity. Sensitivity will be estimated with 10% of the samples spiked with recombinant Bacillus anthracis lethal factor (LF) used to prepare contrived positive samples.
Detailed description
This is a prospective, non-interventional, multi-center study assessing the clinical specificity of the Anthrax LF Dx System using venous blood samples collected from presumptive anthrax negative adult male and female healthy and symptomatic subjects (non- B. anthracis infected).
Up to 500 subjects may be enrolled to meet the goal of 440 evaluable subjects (220 healthy and 220 symptomatic). Subjects will have one venous blood sample collected from a single time-point tested with the Anthrax LF Dx System. At each clinical site, specimens will be randomly selected such that 10% (40 of 400) of all subjects' venous blood samples (total of 40 [20 healthy and 20 symptomatic]) will be spiked with recombinant B. anthracis LF to prepare a contrived positive sample. An unblinded operator will prepare the spiked samples and provide both the spiked and neat samples to a blinded operator for testing on the Anthrax LF Dx System. Thus, the blinded operator will receive samples that could either be spiked (positive) or neat (presumed negative) to preserve the blind.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy and Symptomatic Subjects | – | Diagnostic Test: Anthrax LF Dx SystemBlood sample testing on the Anthrax LF Dx System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male and female healthy and symptomatic subjects.
Key inclusion criteria (7 listed)
- Male or female subject who is ≥18 years of age
- Subject is willing and able to provide Informed Consent for study participation, prior to any study mandated procedures
- For the healthy human population: Subject is in general good health with a stable health status based on medical history, and the investigator's clinical judgment defined as:
- For the symptomatic human population:
Key exclusion criteria (6 listed)
- Subject has inclusion symptoms and tests positive for COVID-19.
- Subject has previously enrolled in this study, or subject has previously failed screening for this study.
- Subject has any medical or social or psychiatric condition(s) or current substance abuse that, in the opinion of the investigator, would preclude the subject's ability to provide informed consent/assent, or to comply with the study requirements.
- Currently enrolled in an investigational drug or device clinical study in which the primary endpoint has not occurred or occurred within the last 30 days.
- Subject is a nursing home resident.
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 |
|---|---|---|
| Anthrax LF Dx SystemLateral flow immunoassay for the detection of the LF biomarker in whole blood samples. | Diagnostic test | Healthy and Symptomatic Subjects |
Primary outcome
The estimated negative percent agreement (NPA) of the Anthrax LF Dx System test.
Time frame: Day of enrollment
The estimated NPA will be calculated from testing neat specimens from 400 subjects (with presumed negative samples).
Adverse events
Time frame: Within 24 hours of blood draw
All adverse events directly related to specimen collection will be reported.
1 secondary outcome
The estimated percent positive agreement (PPA) of the Anthrax LF Dx System test.
Time frame: Day of enrollment
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anthrax, run by SRI International at 3 sites in United States.
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 6 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: stopped early, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The estimated negative percent agreement (NPA) of the Anthrax LF Dx System test. (time frame: Day of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2023.