NCT03569514

Brief Summary

This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with systemic anthrax. 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 sporadic cases of systemic anthrax patients treated with AIGIV.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Nov 2026

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
8.4 years until next milestone

Study Start

First participant enrolled

November 30, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

June 15, 2018

Last Update Submit

February 4, 2026

Conditions

Anthrax

Keywords

AnthraxBacillus anthracisBacterial infectionAIGIVAnthrax 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 systemic anthrax treated with AIGIV

    Up to Day 30

Secondary Outcomes (1)

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

    Up to Day 30

Other Outcomes (11)

  • Cause-specific mortality rate

    Up to Day 30

  • Mortality rate stratified by number of AIGIV doses administered

    Up to Day 30

  • Mortality rate stratified by AIGIV treatment time from symptom onset

    Up to Day 30

  • +8 more other outcomes

Study Arms (1)

AIGIV

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

Anthrax patients who have received AIGIV.

You may qualify if:

  • Confirmed or suspected systemic anthrax patients in the USA or other jurisdictions (if feasible) treated with AIGIV provided by the Centers for Disease Control and Prevention (CDC).
  • Systemic anthrax defined as a clinically compatible case of gastrointestinal, injectional, or inhalational anthrax; anthrax meningitis or bacteremia; or cutaneous anthrax with systemic effects (i.e. tachycardia, tachypnea, hypotension, hyperthermia, hypothermia, leukocytosis) or with lesions that involve the head, neck or upper torso, or are large, bullous, multiple, or surrounded by significant edema PLUS confirmation by one of the following:
  • Epidemiologically linked to a documented anthrax environmental exposure. Laboratory confirmation by isolation of B. anthracis from an affected tissue or site.
  • Demonstration of B. anthracis antigens in tissues by immunohistochemical staining using both B. anthracis cell wall and capsule monoclonal antibodies.
  • Evidence of B. anthracis DNA; for example, by polymerase chain reaction (PCR) in specimens collected from a normally sterile site (such as blood or cerebrospinal fluid (CSF)) or lesion of other affected tissue(s) (skin, pulmonary, reticuloendothelial, or gastrointestinal).
  • QuickELISA™ Anthrax-PA kit manufactured by Immunetics, Inc. for detection of anti-PA antibodies in serum, plasma, and pleural/ascitic fluid.
  • RedLine Alert™ test manufactured by Tetracore, Inc., for identification of B. anthracis colonies.
  • Informed consent/assent (as applicable).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AnthraxBacterial 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)

November 30, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

February 6, 2026

Record last verified: 2026-02