A Phase 4 interventional study of Collection of samples and Obiltoxaximab in Infection, Bacterial and Anthrax, sponsored by Elusys Therapeutics. Not yet recruiting. Per ClinicalTrials.gov, last updated 2023-07-14.
Sponsored by Elusys Therapeutics · Phase 4, Interventional, and Treatment
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.
75 studies on the registry are indexed under Anthrax; 12 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 57 interventional studies indexed under Anthrax.
Browse Anthrax studies →Elusys Therapeutics is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Compared within Anthrax, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Bacterial Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is an open label, 24-week, single arm field study that will be implemented for subjects who receive FDA-approved obiltoxaximab as part of their medical treatment for inhalational anthrax infection in the United States. Adult subjects will be administered a single, intravenous (IV) dose of 16 mg/kg obiltoxaximab given as part of their medical care. Children will receive a weight-adjusted dose. The primary purpose of the study is to collect data from subjects who have been treated with obiltoxaximab as part of their medical care for inhalational anthrax and to collect additional blood samples for measurement of obiltoxaximab concentrations and presence of anti-therapeutic antibodies (ATA).
Other: Collection of samples · Biological: Obiltoxaximab
To the extent possible, blood samples will be collected from all subjects prior to infusion and at specified time points post-infusion to determine serum obiltoxaximab concentrations and ATA titers. Scavenged blood samples can be utilized, if acceptable, to maximize sample analyses for pharmacokinetic and other investigational parameters. Data on other relevant laboratory testing will only be collected and evaluated if available in the subject's record (eg, protective antigen (PA), anti-PA, anti-lethal factor (LF), anti-edema factor, IgG antibodies, anthrax lethal toxin neutralizing activity, presence of anthrax LF, incidence and duration of B. anthracis bacteremia, and demonstration of B. anthracis antigens in tissues).
Obiltoxaximab standard of care
Also known as: Anthim
Overall survival in suspected, probable, or confirmed cases of inhalational anthrax at Week 24
Overall survival will be summarized by frequency of subjects who completed the study at Week 24, and subjects who died before that visit. Population survival distribution function (SDF) will be estimated using the Kaplan-Meier (KM) method.
Time frame: Up to Week 24
Survival at Day 14 and Day 28
Population survival rates at 14 and 28 days will be estimated using the KM method.
Time frame: Up to Day 28
Duration of survival (to Week 24)
The KM method will be used to estimate duration of survival.
Time frame: Up to Week 24
Disease progression and associated complications rates of anthrax (meningitis, pleural effusion, ventilator support) (to Week 24)
The progression to systemic anthrax infection and complication rates will be summarized using KM estimates associated with time to disease progression and time to complication of anthrax. The population SDFs of time to progression to systemic anthrax infection and of time to complication will be estimated using the KM method. Summary statistics of subjects with disease progression and complication rates will be provided.
Time frame: Up to Week 24
Modified SOFA score (to Week 24)
Modified sequential organ failure assessment (SOFA) scores will be assessed using 5 organ systems (respiratory, liver, cardiovascular, central nervous system, renal).
Time frame: Up to Week 24
Incidence and duration of B. anthracis bacteremia
Incidence and duration of B. anthracis bacteremia will be summarized by total incidence across time points of subjects with bacteremia and time from study drug administration to onset of bacteremia.
Time frame: Up to Week 24
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2023; primary completion for Dec 2023, 0 months later.
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This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Obiltoxaximab
Elusys Therapeutics