[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Emergent BioSolutions\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":133},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,66,87,107],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":24,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100629730","observational-study-of-raxibacumab-in-sporadic-cases-of-systemic-anthrax-100629730",false,"NCT07478471","Observational Study of Raxibacumab in Sporadic Cases of Systemic Anthrax","An Observational Clinical Study of Raxibacumab Use in Sporadic Cases of Systemic Anthrax","Inclusion Criteria:\n\n1. 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).\n2. Patients willing and able to adhere to the procedures stated in the protocol.\n3. Patients (or legally acceptable representative of minors and unconscious adults) willing and able to give written informed consent\u002Fassent (as applicable) to participate in the study.\n\nNote: Systemic anthrax is defined in this protocol as a clinically compatible case of gastrointestinal, injectional, or inhalational anthrax; anthrax meningitis or bacteremia; or cutaneous anthrax with systemic effects (i.e., tachycardia, tachypnea, hypotension, hyperthermia, hypothermia, leukocytosis) or with lesions that involve the head, neck or upper torso, or are large, bullous, multiple, or surrounded by significant edema; plus confirmation by one of the following: Epidemiological link to a documented anthrax environmental exposure and\u002For laboratory test used for confirmation of systemic anthrax diagnosis by one of the following:\n\n* Isolation and culture of Bacillus spp. from an affected tissue or site;\n* Evidence of Bacillus spp. DNA by PCR in biological samples such as blood or cerebrospinal fluid (CSF) or lesion of affected tissue (skin, pulmonary, reticuloendothelial, or gastrointestinal);\n* Molecular Typing by Multiple-Locus Variable number tandem repeat Analysis (MLVA); Susceptibility to lysis by γ-phage;\n* QuickELISA™ Anthrax-PA Kit- Detection of anti-PA antibodies in serum, plasma, or pleural\u002Fascitic fluid or;\n* RedLine Alert™ Test- Qualitative identification of B. anthracis colonies\n\nExclusion Criteria:\n\n* There are no exclusion criteria for subjects enrolling in this study.","ALL",{"count":18,"type":19},10,"ESTIMATED","OBSERVATIONAL","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.\n\nThis 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\u002Fcollection 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.",[23],"Infections, Bacterial",[25,26,27],"Raxibacumab","anthrax","anti-toxin","NOT_YET_RECRUITING","2026-03-13",{"date":31,"type":32},"2026-03-17","ACTUAL",{"date":34,"type":19},"2027-05",{"date":36,"type":19},"2030-12",{"name":38,"class":39},"Emergent BioSolutions","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100329460","observational-study-evaluating-clinical-benefit-and-safety-of-aigiv-anthrasil-in-patients-with-systemic-anthrax-100329460","NCT03569514","Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax","An Observational Clinical Study of AIGIV Use in Sporadic Cases of Systemic Anthrax","Inclusion Criteria:\n\n* Confirmed or suspected systemic anthrax patients in the USA or other jurisdictions (if feasible) treated with AIGIV provided by the Centers for Disease Control and Prevention (CDC).\n* Systemic anthrax defined as a clinically compatible case of gastrointestinal, injectional, or inhalational anthrax; anthrax meningitis or bacteremia; or cutaneous anthrax with systemic effects (i.e. tachycardia, tachypnea, hypotension, hyperthermia, hypothermia, leukocytosis) or with lesions that involve the head, neck or upper torso, or are large, bullous, multiple, or surrounded by significant edema PLUS confirmation by one of the following:\n\nEpidemiologically linked to a documented anthrax environmental exposure. Laboratory confirmation by isolation of B. anthracis from an affected tissue or site.\n\nDemonstration of B. anthracis antigens in tissues by immunohistochemical staining using both B. anthracis cell wall and capsule monoclonal antibodies.\n\nEvidence of B. anthracis DNA; for example, by polymerase chain reaction (PCR) in specimens collected from a normally sterile site (such as blood or cerebrospinal fluid (CSF)) or lesion of other affected tissue(s) (skin, pulmonary, reticuloendothelial, or gastrointestinal).\n\nQuickELISA™ Anthrax-PA kit manufactured by Immunetics, Inc. for detection of anti-PA antibodies in serum, plasma, and pleural\u002Fascitic fluid.\n\nRedLine Alert™ test manufactured by Tetracore, Inc., for identification of B. anthracis colonies.\n\n* Informed consent\u002Fassent (as applicable).\n\nExclusion Criteria:\n\n* There are no exclusion criteria for subjects enrolling in this study.",{"count":18,"type":19},"This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with systemic anthrax. The study is designed to collect information on safety, clinical benefit (such as extent of anthrax illness and survival) and serum concentrations of AIGIV (for AIGIV pharmacokinetics) and anthrax toxins from sporadic cases of systemic anthrax patients treated with AIGIV.",[50],"Anthrax",[50,52,53,54,55,56,57],"Bacillus anthracis","Bacterial infection","AIGIV","Anthrax immune globulin","Anti toxin","Polyclonal antibodies","2026-02-04",{"date":60,"type":32},"2026-02-06",{"date":62,"type":19},"2026-11-30",{"date":64,"type":19},"2027-08",{"name":38,"class":39},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100329463","a-field-study-evaluating-clinical-benefit-and-safety-of-aigiv-anthrasil-in-inhalational-anthrax-patients-100329463","NCT03569553","A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients","A Field Study for the Evaluation of AIGIV Clinical Benefit and Safety in the Treatment of Patients With Inhalational Anthrax in a Broad Exposure Event Scenario","Inclusion Criteria:\n\n* Confirmed or suspected inhalational anthrax linked to an identified broad exposure scenario.\n* Treatment with AIGIV.\n* Informed consent\u002Fassent (as applicable).\n\nExclusion Criteria:\n\n* There are no exclusion criteria for subjects enrolling in this study.",{"count":74,"type":19},100,"This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with inhalational anthrax. This study will be implemented only in the event of a major anthrax exposure event. The study is designed to collect information on safety, clinical benefit (such as extent of anthrax illness and survival) and serum concentrations of AIGIV (for AIGIV pharmacokinetics) and anthrax toxins from inhalational anthrax patients treated with AIGIV.",[77],"Inhalational Anthrax",[50,52,79,53,54,80,55,56,57],"Inhalational anthrax","Anthrasil",{"date":60,"type":32},{"date":83,"type":19},"2027-05-30",{"date":85,"type":19},"2027-07",{"name":38,"class":39},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":4},"100222785","phase-4-clinical-benefit-and-safety-of-raxibacumab-in-patients-with-symptomatic-inhalational-anthrax-in-a-mass-exposure-scenario-100222785","NCT02177721","Clinical Benefit and Safety of Raxibacumab in Patients With Symptomatic Inhalational Anthrax in a Mass Exposure Scenario","A Field Study to Evaluate the Clinical Benefit and Safety of Raxibacumab in Patients With Symptomatic Inhalational Anthrax in a Mass Exposure Scenario","Inclusion Criteria:\n\n* Symptomatic inhalational anthrax linked to an identified mass exposure to B. anthracis.\n* Women, including pregnant and lactating women, men, and children of all ages who receive a dose of raxibacumab from the Strategic National Stockpile (SNS) as part of their clinical care for symptomatic inhalational anthrax will be eligible to enroll in this study.\n* Patients willing and able to adhere to the procedures stated in the protocol.\n* Patients (or legally acceptable representative of minors and unconscious adults) willing and able to give written informed consent\u002Fassent (as applicable) to participate in the study.\n\nExclusion Criteria:\n\n* There are no exclusion criteria for patients enrolling in this study.",{"count":74,"type":19},"INTERVENTIONAL",[97],"PHASE4","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.",[23],[25,26,27],{"date":60,"type":32},{"date":103,"type":19},"2027-01",{"date":105,"type":19},"2035-12",{"name":38,"class":39},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":4},"100613593","evaluation-of-clinical-benefit-and-safety-following-cyfendus-administration-for-post-exposure-prophylaxis-of-anthrax-disease-100613593","NCT07268612","Evaluation of Clinical Benefit and Safety Following CYFENDUS Administration for Post-Exposure Prophylaxis of Anthrax Disease.","A Phase 4 Retrospective Observational Study of CYFENDUS™ Anthrax Vaccine Among Individuals Who Received Post-Exposure Prophylaxis Vaccination During a Bacillus Anthracis Mass Exposure Event","Inclusion Criteria:\n\n* Individuals who received any dose of CYFENDUS vaccine (with or without concurrent recommended antibacterial regimen) for anthrax post exposure prophylaxis during an identified mass B. anthracis exposure event in the United States.\n\nExclusion Criteria:\n\n* Individuals who did not receive CYFENDUS for anthrax post exposure prophylaxis during an identified mass B. anthracis exposure event in the United States.",{"count":115,"type":19},250,"The goal of this observational study is to evaluate the safety and clinical benefit of two doses of CYFENDUS vaccine when used with the concurrent recommended antibacterial regimen for post-exposure prophylaxis to prevent inhalational anthrax and\u002For anthrax meningitis.",[50],[50,119,120,121,122,123,124],"Anthrax meningitis","cutaneous anthrax","gastrointestinal anthrax","inhalational anthrax","CYFENDUS","Anthrax vaccine adsorbed adjuvanted","2025-12-04",{"date":127,"type":32},"2025-12-08",{"date":129,"type":19},"2035-11",{"date":131,"type":19},"2037-11",{"name":38,"class":39},""]