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Clinical Benefit and Safety of Raxibacumab in Patients With Symptomatic Inhalational Anthrax in a Mass Exposure Scenario

StatusNot Yet Recruiting
PhasePhase 4
Started
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Record History

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  1. Start date: May 2026 to Jan 2027v12
  2. Primary completion date: Jul 2025 to May 2035v11 Show 9 more changesShow less
    • Start date: Sep 2021 to May 2026
    • Primary endpoints: 3 to 1
    • Study completion date: Jul 2025 to Dec 2035
    • Interventions: Collection of samples (Biological) to Sample Collection (Biological)
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: 17 to 1
    • Study description expanded, about 6 words
    • Collaborators: 3 to 2
    • Study title expanded, about 4 words
  3. Start date: Sep 2019 to Sep 2021v10
  4. Study title shortened, about 6 wordsv9
  5. Lead sponsor: GlaxoSmithKline to Emergent BioSolutionsv8 Show 4 more changesShow less
    • Primary and study completion dates: Apr 1, 2021 to Jul 2025
    • Start date: Sep 28, 2018 to Sep 2019
    • Collaborators: 2 to 3
    • Study title shortened, about 2 words
Show 6 earlier versionsHide 6 earlier versions
  1. Primary and study completion dates: Apr 1, 2020 to Apr 1, 2021
    • Start date: Sep 29, 2017 to Sep 28, 2018
    v7
  2. Primary endpoints revised (3)
    • Primary and study completion dates: Apr 2020 to Apr 1, 2020
    • Start date: Sep 2017 to Sep 29, 2017
    • Interventions: Collection of samples (Other) to Collection of samples (Biological)
    v6
  3. Primary and study completion dates: Mar 2018 to Apr 2020
    • Start date: Sep 2016 to Sep 2017
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Start date: Sep 2015 to Sep 2016v3
  6. Start date: Sep 2014 to Sep 2015v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This field study is designed such that it may be implemented for any individual with symptomatic inhalational anthrax who has been administered raxibacumab for treatment of anthrax following a mass exposure scenario. This study is designed to describe the clinical effectiveness (including course of illness and survival) and safety profile from patients who are treated with raxibacumab as part of their clinical care following exposure to B. anthracis. Study data 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 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.
Trial Details
NCT Number NCT02177721
Lead Sponsor Emergent BioSolutions
Collaborators: Centers for Disease Control and Prevention, Biomedical Advanced Research and Development Authority
Conditions
(from sponsor)		 Infections, Bacterial
Related terms Anthrax, Bacterial Infections
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov