Clinical trial NCT03088111: An Open Label Field Study of Anthim (Obiltoxaximab) in Subjects Exposed to B. Anthracis
Official title: A Phase 4, Open Label Field Study to Evaluate the Clinical Benefit, Safety, and Pharmacokinetics of Anthim (Obiltoxaximab) When Used in the Treatment of Suspected, Probable, or Confirmed Cases of Inhalational Anthrax Due to B. Anthracis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Infection, Bacterial
Anthrax
Keywords: Anthim®
Obiltoxaximab
anthrax
anti-toxin
Lead sponsor: Elusys Therapeutics
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: APCER Life Sciences
First posted: 2017-03-23
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label
Primary purpose: TREATMENT

Brief summary: This field study is a post-marketing requirement from the FDA to evaluate the clinical benefit (course of illness and survival), safety and pharmacokinetics of obiltoxaximab administered to patients as part of their medical care for treatment or prophylaxis of inhalational anthrax infection following exposure to Bacillus anthracis (B. anthracis). The protocol can be implemented for any individual who receives obiltoxaximab for a suspected, probable, or confirmed case of inhalational anthrax due to B. anthracis in the United States, including sporadic cases, small incidents and/or a mass event. In case of a small anthrax incident, to the extent possible, the information will be collected prospectively at prespecified time points, except where it would interfere with management of the subject's illness. However, because of the logistical complexities that would likely accompany a mass anthrax event, most data in this study are anticipated to be collected retrospectively. Both retrospective and prospective data collection are allowed to maximize information collection. This study will collect data on the use of obiltoxaximab in anthrax infected or exposed subjects and the data collected will inform the understanding of the clinical benefit and safety of obiltoxaximab.


Eligibility criteria: Inclusion Criteria:

* Men and women (including pregnant and lactating women) and children of all ages who receive obiltoxaximab as part of their clinical care for anthrax infection and are willing and able to give written informed consent themselves or through legally acceptable representative (for minors, unconscious adults or deceased subjects) to participate in the study

Exclusion Criteria:

* There are no exclusion criteria defined for this study

Primary outcomes:
measure: Overall survival in suspected, probable, or confirmed cases of inhalational anthrax at Week 24
timeFrame: Up to Week 24
Secondary outcomes:
measure: Survival at Day 14 and Day 28
timeFrame: Up to Day 28
measure: Duration of survival (to Week 24)
timeFrame: Up to Week 24
measure: Disease progression and associated complications rates of anthrax (meningitis, pleural effusion, ventilator support) (to Week 24)
timeFrame: Up to Week 24
measure: Modified SOFA score (to Week 24)
timeFrame: Up to Week 24
measure: Incidence and duration of B. anthracis bacteremia
timeFrame: Up to Week 24
Other outcomes:
Locations:
Study officials:
affiliation: NightHawk Biosciences
name: Vice President Clinical Development
role: STUDY_DIRECTOR
affiliation: Contract Medical Monitor
name: Timothy S. Leach, MD, MPH
role: STUDY_DIRECTOR
References: