A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients
- Registration Number
- NCT03569553
- Lead Sponsor
- Emergent BioSolutions
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Confirmed or suspected inhalational anthrax linked to an identified broad exposure scenario.
- Treatment with AIGIV.
- Informed consent/assent (as applicable).
- There are no exclusion criteria for subjects enrolling in this study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description AIGIV AIGIV Inhalational anthrax patients who have been administered AIGIV (ANTHRASIL®) as per licensed US prescribing information.
- Primary Outcome Measures
Name Time Method Assessment of AIGIV clinical benefit by overall mortality rate Up to Day 30 Mortality rate (incidence of death) in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV
- Secondary Outcome Measures
Name Time Method Assessment of AIGIV clinical benefit by time from symptom onset to death Up to Day 30 Time from symptom onset to death in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV
Assessment of AIGIV clinical benefit by mortality rate at Day 7 and Day 30 Up to Day 30 Difference in mortality rate at Day 7 and Day 30 after AIGIV administration to patients with confirmed diagnosis of inhalational anthrax
Assessment of AIGIV safety by incidence of serious adverse drug reactions and serious suspected adverse drug reactions Up to Day 30 Combined incidence of serious adverse drug reactions (ie, serious adverse events related to AIGIV administration) and serious suspected adverse drug reactions (ie, serious adverse events that occur during or within 24 hours following AIGIV administration) in individuals treated with AIGIV
Mortality rate stratified by number of AIGIV doses administered Up to Day 30 Number of deaths stratified by number of AIGIV doses (single versus multiple doses) in patients with confirmed diagnosis of systemic anthrax treated with AIGIV