Clinical trial NCT02177721: Clinical Benefit, Safety and PK of Raxibacumab in Subjects Exposed to Bacillus Anthracis
Official title: A Phase 4, Open-label Field Study (200137) to Evaluate the Clinical Benefit, Safety and Pharmacokinetics in Subjects Treated With Raxibacumab (GSK3068483) Following Exposure to Bacillus Anthracis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Infections, Bacterial
Keywords: Raxibacumab
anthrax
anti-toxin
Lead sponsor: Emergent BioSolutions
Sponsor class: INDUSTRY
Collaborators: name: Centers for Disease Control and Prevention
name: Department of Health and Human Services
name: GlaxoSmithKline
First posted: 2014-06-30
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This field study is designed such that it may be implemented for any individual who has been administered raxibacumab for treatment of anthrax or for post-exposure prophylaxis including sporadic cases, small anthrax incidents and/or a mass event. This study is designed to describe the clinical effectiveness (including course of illness and survival), safety profile, and raxibacumab pharmacokinetics (PK) from patients who are treated with raxibacumab as part of their clinical care following exposure to B. anthracis. Study data and samples for PK and other investigational research will be collected prospectively to the extent possible at pre-specified time points. However, because of the logistical complexities that would likely accompany a mass anthrax event, most data in this study is anticipated to be collected retrospectively. During such a mass anthrax event scavenged blood samples will be utilized where possible to maximize sample analyses for PK and other investigational parameters. Therefore, both retrospective and prospective data collection are allowed in this protocol in order to maximize the amount of information obtained in subjects who have been administered raxibacumab. This field study will be the first opportunity to collect data on B. anthracis-exposed patients treated with raxibacumab, to better understand the clinical benefit and safety of the drug and to further inform patient care and treatment choices for management of anthrax

Detailed description: The protocol is a post-marketing requirement from the FDA to evaluate the clinical benefit, safety and pharmacokinetic of raxibacumab administered to patients as part of their medical care following exposure to Bacillus anthracis.

Eligibility criteria: Inclusion Criteria:

* Women-including pregnant and lactating women, men, and children of all ages who receive treatment with raxibacumab as part of their clinical care for anthrax infection or for post-exposure prophylaxis will be eligible to enroll in this study.
* Subjects willing and able to adhere to the procedures stated in the protocol
* Subjects or legally acceptable representative of minors and unconscious adults willing and able to give written informed consent to participate in the study.

Exclusion Criteria:

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

Primary outcomes:
measure: Assessment of clinical benefit by overall survival for cohort 1
timeFrame: Up to Week 24
measure: Assessment of clinical benefit by emergence rate of systemic anthrax infection for Cohort 2
timeFrame: Up to Week 24
measure: Assessment of clinical benefit by rate of resolution of edema and healing of lesion without emergence of systemic anthrax infection for cohort 3
timeFrame: Up to Week 24
Secondary outcomes:
measure: Survival rate on Day 14 and Day 28
timeFrame: Up to Day 28
measure: Length of (Intensive Care Unit) ICU stay
timeFrame: Up to Week 24
measure: Incidence of associated complication of anthrax (meningitis, pleural effusion)
timeFrame: Up to Day 28
measure: Incidence of the progression of the disease clinical stage for subject in Cohort 1
timeFrame: Up to Week 24
measure: Incidence of the progression to systemic anthrax infection for subjects in Cohorts 2 and 3
timeFrame: Up to Week 24
measure: Summary of the area of wound/lesions for subjects in Cohort 3
timeFrame: Up to Week 24
measure: Summary of significant concurrent medical treatment
timeFrame: Up to Week 24
measure: Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Week 24
measure: Summary of ECG data
timeFrame: Up to Week 24
measure: Summary of Vital Signs
timeFrame: Up to Week 24
measure: Summary of serum raxibacumab concentrations
timeFrame: Up to Week 24
measure: Summary of disease markers: Protective Antigen (PA), toxin neutralizing antibody (TNA) and Anti-drug antibody (ADA) levels
timeFrame: Up to Week 24
measure: Length of hospital stay
timeFrame: Up to Week 24
measure: Summary of neurological function as assessed by Glasgow Coma Scale or Adelaide Pediatric Scale
timeFrame: Up to 24 weeks
measure: Summary of daily functionality as assessed by Katz ADL
timeFrame: Up to 24 weeks
measure: Incidence of bacteremia
timeFrame: Up to 24 weeks
measure: Summary of clinical chemistry and hematology laboratory data
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Emergent BioSolutions
name: Christine Hall, PhD
role: STUDY_DIRECTOR
References: