[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100329460":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":10,"responsibleParty":31,"collaborators":33,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":10,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":10,"maxAge":10,"enrollmentInfo":47,"targetDuration":10,"studyType":50,"phases":10,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":60,"whyStopped":10,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":10},{"fullName":5,"class":6},"Emergent BioSolutions","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"AIGIV",null,"Anthrax patients who have been administered AIGIV (ANTHRASIL®) as per licensed US prescribing information.",[13],"Drug: AIGIV",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Anthrax Immune Globulin Intravenous (Human)",[9],[20],"ANTHRASIL®",[22],{"name":23,"affiliation":10,"role":24},"Brandon Essink, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Clinical Development Representative","CONTACT","240-631-3200","ctgov@ebsi.com",{"type":32,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[34,37],{"name":35,"class":36},"Centers for Disease Control and Prevention","FED",{"name":38,"class":36},"Department of Health and Human Services","100329460","observational-study-evaluating-clinical-benefit-and-safety-of-aigiv-anthrasil-in-patients-with-systemic-anthrax-100329460",false,"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.","ALL",{"count":48,"type":49},10,"ESTIMATED","OBSERVATIONAL","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.",[53],"Anthrax",[53,55,56,9,57,58,59],"Bacillus anthracis","Bacterial infection","Anthrax immune globulin","Anti toxin","Polyclonal antibodies","NOT_YET_RECRUITING","2026-02-04",{"date":63,"type":64},"2026-02-06","ACTUAL",{"date":66,"type":49},"2026-11-30",{"date":68,"type":49},"2027-08",{"name":5,"class":6}]