An observational study in Anthrax, sponsored by SRI International. Terminated at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by SRI International · Observational
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.
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.
75 studies on the registry are indexed under Anthrax; 12 are open to participants now.
This study's enrollment of 343 is above the median of 99 across 16 observational studies indexed under Anthrax.
Browse Anthrax studies →SRI International is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult male and female healthy and symptomatic subjects.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood sample testing on the Anthrax LF Dx System
Diagnostic Test: Anthrax LF Dx System
Lateral flow immunoassay for the detection of the LF biomarker in whole blood samples.
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).
Time frame: Day of enrollment
Adverse events
All adverse events directly related to specimen collection will be reported.
Time frame: Within 24 hours of blood draw
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.
Time frame: Day of enrollment
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2023 to primary completion in Apr 2023, 2 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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SRI International