Clinical trial NCT03569553: A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients
Official title: A Field Study for the Evaluation of AIGIV Clinical Benefit and Safety in the Treatment of Patients With Inhalational Anthrax in a Broad Exposure Event Scenario
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Inhalational Anthrax
Keywords: Anthrax
Bacillus anthracis
Inhalational anthrax
Bacterial infection
AIGIV
Anthrasil
Anthrax immune globulin
Anti toxin
Polyclonal antibodies
Lead sponsor: Emergent BioSolutions
Sponsor class: INDUSTRY
Collaborators: name: Centers for Disease Control and Prevention
name: Department of Health and Human Services
First posted: 2018-06-26
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inhalational anthrax patients who have received AIGIV.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* There are no exclusion criteria for subjects enrolling in this study.

Primary outcomes:
measure: Assessment of AIGIV clinical benefit by overall mortality rate
timeFrame: Up to Day 30
Secondary outcomes:
measure: Assessment of AIGIV clinical benefit by time from symptom onset to death
timeFrame: Up to Day 30
measure: Assessment of AIGIV clinical benefit by mortality rate at Day 7 and Day 30
timeFrame: Up to Day 30
measure: Assessment of AIGIV safety by incidence of serious adverse drug reactions and serious suspected adverse drug reactions
timeFrame: Up to Day 30
measure: Mortality rate stratified by number of AIGIV doses administered
timeFrame: Up to Day 30
Other outcomes:
measure: Cause-specific mortality rate
timeFrame: Up to Day 30
measure: Mortality rate stratified by AIGIV treatment time from symptom onset
timeFrame: Up to Day 30
measure: Mortality rate stratified by acute physiologic assessment and chronic health evaluation (APACHE) II score at baseline
timeFrame: Up to Day 30
measure: Duration of hospitalization
timeFrame: Up to Day 30
measure: Duration of intensive care unit (ICU) hospitalization
timeFrame: Up to Day 30
measure: Incidence of ICU hospitalization
timeFrame: Up to Day 30
measure: Duration of mechanical ventilation
timeFrame: Up to Day 30
measure: Evaluation of sequential organ failure assessment (SOFA) score
timeFrame: Up to Day 14
measure: Assessment of AIGIV pharmacokinetics
timeFrame: Up to Day 7
measure: Assessment of anthrax toxin levels (protective antigen and lethal factor)
timeFrame: Up to Day 7
Locations:
Study officials:
name: Brandon Essink, MD
role: PRINCIPAL_INVESTIGATOR
References: