A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2027-05-30

Study Completion Date

2027-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with inhalational anthrax. This study will be implemented only in the event of a major anthrax exposure event. The study is designed to collect information on safety, clinical benefit (such as extent of anthrax illness and survival) and serum concentrations of AIGIV (for AIGIV pharmacokinetics) and anthrax toxins from inhalational anthrax patients treated with AIGIV.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)

NCT00845650

Anthrax

COMPLETED PHASE1/PHASE2

NasoShield in Healthy Adults to Study Safety and Immunogenicity

NCT04415749

Healthy Volunteers

COMPLETED PHASE1

Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine

NCT05313035

COVID-19

COMPLETED PHASE2/PHASE3

Safety and Immunogenicity of a Hantaan Virus DNA Vaccine and a Puumala Virus DNA Vaccine, For The Prevention of Hemorrhagic Fever With Renal Syndrome

NCT04333459

Hantaan Virus Nephropathy Puumala Virus Nephropathy

UNKNOWN PHASE2

Admission and Management of Occupational or Other Exposures to Biodefense/Bioterrorism Agents or to Epidemic/Emerging Infectious Diseases

NCT01200953

Occupational Accidents Incubation Period, Infectious Disese

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is a post-marketing requirement from the FDA to evaluate safety and clinical benefit of AIGIV administered to patients as part of their medical care after inhalational exposure to Bacillus anthracis. Study information (i.e. data on safety and clinical benefit evaluation of AIGIV up to Day 30 following administration) and patient samples (for assessment of AIGIV pharmacokinetics and anthrax toxin levels) will be collected (up to Day 7 following AIGIV administration) prospectively to the extent possible; however, due to logistical complexities that will likely occur during a mass anthrax exposure event, most data for this study will be collected retrospectively (including scavenged patient samples for assessment of serum AIGIV concentration and anthrax toxin levels). Therefore, both prospective and retrospective data collection are allowed in this study to maximize the amount of information obtained from inhalational anthrax patients who have been administered AIGIV.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inhalational Anthrax

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AIGIV

Inhalational anthrax patients who have been administered AIGIV (ANTHRASIL®) as per licensed US prescribing information.

AIGIV

Intervention Type DRUG

Anthrax Immune Globulin Intravenous (Human)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AIGIV

Anthrax Immune Globulin Intravenous (Human)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ANTHRASIL®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Confirmed or suspected inhalational anthrax linked to an identified broad exposure scenario.
* Treatment with AIGIV.
* Informed consent/assent (as applicable).

Eligible Sex

ALL

Accepts Healthy Volunteers

No