Clinical trial NCT03569514: Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax
Official title: An Observational Clinical Study of AIGIV Use in Sporadic Cases of Systemic Anthrax
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anthrax
Keywords: Anthrax
Bacillus anthracis
Bacterial infection
AIGIV
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: 10
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: Anthrax patients who have received AIGIV.

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.

Detailed description: This study is a post-marketing requirement from the FDA to evaluate safety and clinical benefit of AIGIV administered to systemic anthrax patients as part of their medical care after exposure to Bacillus anthracis (anthrax exposure can be via inhalation, ingestion, injection). 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, in some cases data may 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 systemic anthrax patients who have been treated with AIGIV.

Eligibility criteria: Inclusion Criteria:

* 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).

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 safety by incidence of serious adverse drug reactions and serious suspected adverse drug reactions
timeFrame: Up to Day 30
Other outcomes:
measure: Cause-specific mortality rate
timeFrame: Up to Day 30
measure: Mortality rate stratified by number of AIGIV doses administered
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: