NCT03569553

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started May 2027

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
8.9 years until next milestone

Study Start

First participant enrolled

May 30, 2027

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

1 month

First QC Date

June 15, 2018

Last Update Submit

February 4, 2026

Conditions

Inhalational Anthrax

Keywords

AnthraxBacillus anthracisInhalational anthraxBacterial infectionAIGIVAnthrasilAnthrax immune globulinAnti toxinPolyclonal antibodies

Outcome Measures

Primary Outcomes (1)

  • Assessment of AIGIV clinical benefit by overall mortality rate

    Mortality rate (incidence of death) in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV

    Up to Day 30

Secondary Outcomes (4)

  • Assessment of AIGIV clinical benefit by time from symptom onset to death

    Up to Day 30

  • Assessment of AIGIV clinical benefit by mortality rate at Day 7 and Day 30

    Up to Day 30

  • Assessment of AIGIV safety by incidence of serious adverse drug reactions and serious suspected adverse drug reactions

    Up to Day 30

  • Mortality rate stratified by number of AIGIV doses administered

    Up to Day 30

Other Outcomes (10)

  • Cause-specific mortality rate

    Up to Day 30

  • Mortality rate stratified by AIGIV treatment time from symptom onset

    Up to Day 30

  • Mortality rate stratified by acute physiologic assessment and chronic health evaluation (APACHE) II score at baseline

    Up to Day 30

  • +7 more other outcomes

Study Arms (1)

AIGIV

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

Drug: AIGIV

Interventions

AIGIVDRUG

Anthrax Immune Globulin Intravenous (Human)

Also known as: ANTHRASIL®
AIGIV

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inhalational anthrax patients who have received AIGIV.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Inhalation anthraxAnthraxBacterial Infections

Interventions

Anthrax Immune Globulin Intravenous

Condition Hierarchy (Ancestors)

Bacillaceae InfectionsGram-Positive Bacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Brandon Essink, MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Development Representative

CONTACT

240-631-3200ctgov@ebsi.com

Study Design

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

Study Record Dates

First Submitted

June 15, 2018

First Posted

June 26, 2018

Study Start (Estimated)

May 30, 2027

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

February 6, 2026

Record last verified: 2026-02