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Trial record 5 of 5 for:    "Anthrax Disease" | "Immunoglobulins, Intravenous"

A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients

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ClinicalTrials.gov Identifier: NCT03569553
Recruitment Status : Not yet recruiting
First Posted : June 26, 2018
Last Update Posted : January 29, 2019
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Department of Health and Human Services
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Inhalational Anthrax Drug: 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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anthrax
Drug Information available for: Anthrasil

Group/Cohort Intervention/treatment
AIGIV
Inhalational anthrax patients who have been administered AIGIV (ANTHRASIL®) as per licensed US prescribing information.
Drug: AIGIV
Anthrax Immune Globulin Intravenous (Human)
Other Name: ANTHRASIL®




Primary Outcome Measures :
  1. Assessment of AIGIV clinical benefit by overall mortality rate [ Time Frame: Up to Day 30 ]
    Mortality rate (incidence of death) in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV


Secondary Outcome Measures :
  1. Assessment of AIGIV clinical benefit by time from symptom onset to death [ Time Frame: Up to Day 30 ]
    Time from symptom onset to death in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV

  2. Assessment of AIGIV clinical benefit by mortality rate at Day 7 and Day 30 [ Time Frame: 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

  3. Assessment of AIGIV safety by incidence of serious adverse drug reactions and serious suspected adverse drug reactions [ Time Frame: 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

  4. Mortality rate stratified by number of AIGIV doses administered [ Time Frame: 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


Other Outcome Measures:
  1. Cause-specific mortality rate [ Time Frame: Up to Day 30 ]
    Number of deaths assigned to a specific cause in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV

  2. Mortality rate stratified by AIGIV treatment time from symptom onset [ Time Frame: Up to Day 30 ]
    Number of deaths stratified by AIGIV treatment time from symptom onset (early versus late onset of symptoms) in patients with confirmed diagnosis of inhalational anthrax

  3. Mortality rate stratified by acute physiologic assessment and chronic health evaluation (APACHE) II score at baseline [ Time Frame: Up to Day 30 ]
    Number of deaths stratified by APACHE II score at baseline in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV

  4. Duration of hospitalization [ Time Frame: Up to Day 30 ]
    Length of hospitalization in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV

  5. Duration of intensive care unit (ICU) hospitalization [ Time Frame: Up to Day 30 ]
    Length of ICU stay in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV

  6. Incidence of ICU hospitalization [ Time Frame: Up to Day 30 ]
    Number of patients with confirmed diagnosis of inhalational anthrax treated with AIGIV admitted to ICU

  7. Duration of mechanical ventilation [ Time Frame: Up to Day 30 ]
    Length of mechanical ventilation in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV

  8. Evaluation of sequential organ failure assessment (SOFA) score [ Time Frame: Up to Day 14 ]
    Increase in SOFA score from baseline in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV

  9. Assessment of AIGIV pharmacokinetics [ Time Frame: Up to Day 7 ]
    Serum concentration of AIGIV over time in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV to determine AIGIV pharmacokinetic parameters such as maximum serum concentration, area under the concentration versus time (i.e, level of AIGIV circulating over time) and clearance

  10. Assessment of anthrax toxin levels (protective antigen and lethal factor) [ Time Frame: Up to Day 7 ]
    Levels of anthrax toxins (protective antigen and lethal factor) over time in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inhalational anthrax patients who have received AIGIV.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569553


Contacts
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Contact: Christine Hall, PhD 204 275 4248 chall@ebsi.com

Sponsors and Collaborators
Emergent BioSolutions
Centers for Disease Control and Prevention
Department of Health and Human Services
Investigators
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Principal Investigator: Brandon Essnik, MD

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Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT03569553     History of Changes
Other Study ID Numbers: AX-003A
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emergent BioSolutions:
Anthrax
Bacillus anthracis
Inhalational anthrax
Bacterial infection
AIGIV
Anthrasil
Anthrax immune globulin
Anti toxin
Poluclonal antibodies
Additional relevant MeSH terms:
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Anthrax
Respiratory Tract Infections
Bacillaceae Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Infection
Respiratory Tract Diseases
Antitoxins
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs