NCT05672875

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
343

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

January 23, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2023

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

January 3, 2023

Last Update Submit

November 27, 2023

Conditions

Anthrax

Outcome Measures

Primary Outcomes (2)

  • 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).

    Day of enrollment

  • Adverse events

    All adverse events directly related to specimen collection will be reported.

    Within 24 hours of blood draw

Secondary Outcomes (1)

  • The estimated percent positive agreement (PPA) of the Anthrax LF Dx System test.

    Day of enrollment

Study Arms (1)

Healthy and Symptomatic Subjects

Blood sample testing on the Anthrax LF Dx System

Diagnostic Test: Anthrax LF Dx System

Interventions

Anthrax LF Dx SystemDIAGNOSTIC_TEST

Lateral flow immunoassay for the detection of the LF biomarker in whole blood samples.

Healthy and Symptomatic Subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult male and female healthy and symptomatic subjects.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

WellNow Urgent Care and Research

Cincinnati, Ohio, 45215, United States

Location

WellNow Urgent Care and Research

Columbus, Ohio, 43214, United States

Location

WellNow Urgent Care and Research

Dayton, Ohio, 45373, United States

Location

MeSH Terms

Conditions

Anthrax

Condition Hierarchy (Ancestors)

Bacillaceae InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

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

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 5, 2023

Study Start

January 23, 2023

Primary Completion

April 20, 2023

Study Completion

April 20, 2023

Last Updated

November 30, 2023

Record last verified: 2023-11

Locations

US(3)