Observational Study of Raxibacumab in Sporadic Cases of Systemic Anthrax
ConditionInfections, Bacterial
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorEmergent BioSolutions
About this trial
This observational, open-label, single arm, study is designed such that it may be implemented for any individual with a lab confirmed sporadic case of systemic anthrax disease treated with raxibacumab outside of the current United States Prescribing Information (USPI). Systemic anthrax cases may include inhalational, gastrointestinal and injectional anthrax, anthrax meningitis or bacteremia or cutaneous anthrax with systemic effects.
This study is designed to evaluate the clinical effectiveness (including course of illness and survival), safety profile and pharmacokinetic (PK) analysis of raxibacumab from patients who are treated with raxibacumab as part of their clinical care following exposure to B. anthracis. Study data, PK sample provision/collection and other investigational research will be collected prospectively to the extent possible at pre-specified time points. However, there is no reasonable way to identify prospectively the individuals likely to become eligible for participation in this study so most data in this study is anticipated to be collected retrospectively. Scavenged blood samples will be utilized where possible to maximize sample analyses 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any patient (women, including pregnant and lactating women, men, and children of all ages) with lab confirmed systemic anthrax in the US treated with a dose of raxibacumab from the Strategic National Stockpile (SNS).
Patients willing and able to adhere to the procedures stated in the protocol.
Patients (or legally acceptable representative of minors and unconscious adults) willing and able to give written informed consent/assent (as applicable) to participate in the study.
Isolation and culture of Bacillus spp. from an affected tissue or site;
Disqualifiers
There are no exclusion criteria for subjects enrolling in this study.
Trial population
The population to be studied are patients with lab confirmed systemic anthrax who are treated with raxibacumab according to the USPI and distributed from the US SNS. The population may include all age categories of patients (infant, pediatric, adult \[including pregnant and lactating women\], and geriatric) with confirmed systemic anthrax in the US.
Trial design
Design model
Case-only
Time perspective
Other
Treatments tested in this trial
Collection of samples
Biological/VaccineWhenever possible serum samples will be collected from all subjects to determine serum raxibacumab concentrations pre-infusion, and at specific timepoints post-infusion. In the event cerebrospinal fluid (CSF), pleural, ascites, or bronchoalveolar lavage (BAL) fluid are collected for ad hoc clinical laboratory testing, any remaining excess sample will be provided to Sponsor for determination of raxibacumab concentrations. Any available serum remaining from ad hoc clinical laboratory specimen collections prior to raxibacumab administration will be provided to Sponsor for measurement of serum PA concentrations. In addition, remaining post raxibacumab dose serum specimens may also be analyzed for lethal factor (LF) levels.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Raxibacumab arm1 intervention
Trial outcomes
Primary outcomes
1
Clinical Benefit of Raxibacumab for Patients with Confirmed Systemic Anthrax Disease
The primary objective is: To evaluate the clinical benefit in patients with confirmed systemic anthrax disease, as assessed by overall mortality rate up to Day 29.
Time frame
Up to Day 292
Clinical Benefit of Raxibacumab for Patients with Confirmed Systemic Anthrax Disease
The primary objective is: To evaluate safety of raxibacumab in patients with confirmed systemic anthrax disease, as assessed by incidence of ADRs.
Time frame
Up to Day 293
Clinical Benefit of Raxibacumab for Patients with Confirmed Systemic Anthrax Disease
The primary objective is: To evaluate safety of raxibacumab in patients with confirmed systemic anthrax disease, as assessed by incidence of SAEs.
Time frame
Up to Day 29Secondary outcomes
1
To evaluate the clinical course of the disease in patients with confirmed systemic anthrax disease
The secondary objective is to evaluate the clinical course of the disease in patients with confirmed systemic anthrax disease assessed by Incidence of hospitalization
Time frame
Up to Day 292
To evaluate the clinical course of the disease in patients with confirmed systemic anthrax disease
The secondary objective is to evaluate the clinical course of the disease in patients with confirmed systemic anthrax disease assessed by length of hospitalization
Time frame
Up to Day 293
To evaluate the clinical course of the disease in patients with confirmed systemic anthrax disease
The secondary objective is to evaluate the clinical course of the disease in patients with confirmed systemic anthrax disease assessed by length of ICU stay.
Time frame
Up to Day 294
To evaluate the clinical course of the disease in patients with confirmed systemic anthrax disease
The secondary objective is to evaluate the clinical course of the disease in patients with confirmed systemic anthrax disease assessed by duration of mechanical ventilation
Time frame
Up to Day 29Other outcomes
1
Anti-PA serum concentrations
Assess anti-PA serum concentrations to the extent that data permit.
Time frame
Up to Day 292
Anthrax toxin levels
Assess anthrax toxin levels to the extent that data permit.
Time frame
Up to Day 293
Raxibacumab PK in Relation to Anthrax Toxemia
Inform on raxibacumab PK parameter of Cmax, in relation to anthrax toxemia to the extent that the data permit.
Time frame
Up to Day 294
Raxibacumab PK in Relation to Anthrax Toxemia
Inform on raxibacumab PK parameter of AUC0-inf, in relation to anthrax toxemia to the extent that the data permit.
Time frame
Up to Day 29Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Emergent BioSolutions
Lead sponsor
Centers for Disease Control and Prevention
Collaborator
Department of Health and Human Services
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: