[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anthrax\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anthrax":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":4,"leadSponsor":37,"locationsCount":40},"100061754","natural-history-of-anthrax-a-study-of-primary-infected-recovered-and-exposed-individuals-spore-and-evaluation-of-ava-vaccinated-recipients-100061754",false,"NCT00050310","Natural History of Anthrax: a Study of Primary Infected, Recovered, and Exposed Individuals (SPoRE); and Evaluation of AVA-Vaccinated Recipients","Natural History of Anthrax: A Study of Primary Infected, Recovered, and Exposed (SPoRE) Individuals and Evaluation of AVA Vaccinated Recipients","* INCLUSION CRITERIA:\n\nSubjects at least 3 years old, including pregnant women, are eligible for inclusion if they meet one of the five criteria listed below, are hemodynamically and clinically stable, and agree to stored samples. Women of child-bearing age or potential will not be excluded from participation but pregnancy status will be determined by serum or urine pregnancy test at time of enrollment in order to optimize subsequent evaluation and care.\n\nAlthough the study is open to participants at least 3 years old, pediatric anthrax cases are historically rare and essentially of the cutaneous type. Therefore, few, if any pediatric subjects are expected.\n\nDecisionally impaired subjects will be included in this study only if a Legally Authorized Representative (LAR) understands and is willing to sign a written informed consent document.\n\n1. Inhalation Anthrax (acute or recovering infection)\n\n   CONFIRMED:\n\n   --nonspecific febrile illness followed by sepsis and\u002For respiratory failure\n\n   AND\n\n   --B anthracis isolation (via culture) from any site OR 2 supportive lab tests\n\n   OR SUSPECTED:\n\n   --nonspecific febrile illness followed by sepsis and\u002For respiratory failure with no alternative diagnosis\n\n   AND\n\n   --one supportive lab test OR direct epidemiological link to a confirmed environmental exposure\n2. Cutaneous Anthrax (acute or recovering infection)\n\n   CONFIRMED:\n\n   --characteristic lesion (papule-\\>vesicular-\\>depressed black eschar plus or minus edema, erythema, necrosis, or ulceration)\n\n   AND\n\n   --B anthracis isolation (culture) from any site OR 2 supportive lab tests\n\n   SUSPECTED:\n\n   --Characteristic lesion with no alternative diagnosis\n\n   AND\n\n   --one supportive lab test OR direct epidemiological link to a confirmed environmental exposure\n3. Gastrointestinal Anthrax (acute or recovering infection)\n\n   CONFIRMED:\n\n   --Severe abdominal pain often associated with bloody vomiting\u002Fdiarrhea followed by fever\u002Fsepticemia\n\n   AND\n\n   --B anthracis isolation (culture) from any site OR 2 supportive lab tests\n\n   SUSPECTED:\n\n   --Severe abdominal pain often associated with bloody vomiting\u002Fdiarrhea followed by fever\u002Fsepticemia with no alternative diagnosis\n\n   AND\n\n   --1 supportive lab test OR direct epidemiological link to a confirmed environmental exposure\n\n   These definitions were subsequently updated by the CDC in 2010 to accept clinically compatible symptoms plus one of the following: a positive culture, a positive immunohistochemical stain for antigen, a 4-fold increase in anti-PA IgG or a positive documented exposure with detection of DNA via PCR (26).\n4. Exposed individuals who are clinically asymptomatic.\n5. Past or imminent vaccination in healthy (non-anthrax exposed).\n6. Hemodynamically and clinically stable at time of evaluation at NIH.\n\n   * Hemodynamically: stable vital signs\n   * Clinically: no obvious signs of disease progression (e.g. worsening pleural effusions or increasing cutaneous edema)\n   * acute\u002Fnewly recovered patients must be receiving standard antimicrobial therapy\n7. Participant agrees to stored samples.\n\nEXCLUSION CRITERIA:\n\nInability of subject or Legally Authorized Representative (LAR) to understand or subject not willing to sign a written informed consent document.","ALL","3 Years","100 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","This study will examine pathophysiology and immune response of anthrax in infected or exposed individuals to learn more about the disease symptoms, prevention and response to treatment. In addition, it will evaluate immune response to the anthrax vaccine AVA (Anthrax Vaccine Adsorbed) in healthy, non-infected individuals.\n\nThe following individuals may be eligible for this study:\n\n1. People with confirmed or suspected anthrax (inhalational, cutaneous or gastrointestinal, either acute or recovering);\n2. People exposed to anthrax who have no clinical symptoms.\n3. Healthy people who have not been exposed to anthrax and have been vaccinated with AVA.\n\nThose enrolled in the study will undergo the following tests and procedures.\n\nInfected and exposed individuals:\n\n* Symptomatic participants will have the following clinical procedures if medically necessary:\n* a) blood tests for cell counts, chemistries and evidence of anthrax bacteria;\n* b) nasal swab to test for evidence of anthrax\n* c) chest X-ray;\n* d) computed tomography (CT) scan (special X-rays to examine the lungs or abdomen);\n* e) echocardiogram to examine the heart\n* f) magnetic resonance imaging (MRI), a special imaging test using a magnetic field and radio waves to examine the infected area of skin and soft tissue for patients with cutaneous anthrax.\n* All subjects (with or without symptoms) will have the following research procedures:\n* a) blood tests to examine immune response to anthrax;\n* b) throat swab to test for evidence of anthrax\n* c) nasopharyngeal wash to test for anthrax. Water is sprayed into the nostrils and then allowed to drain for collection in a cup;\n* d) induced sputum to test for presence of and immune response to anthrax. A mask with a saline mist is placed over the subject s mouth and nose, causing the subject to cough and produce sputum from the lungs. The sputum is collected in a cup this is for individuals 18 and older who do not undergo bronchoscopy, described below.\n* Participants 18 years of age and older may have the following optional research procedures:\n* a) leukapheresis or plasmapheresis (see description under non-infected, vaccinated individuals above);\n* b) lymph node biopsy. A sample of lymph node tissue is surgically removed under local anesthetic;\n* c) bronchoalveolar lavage. This 15- to 30-minute procedure is done in the intensive care unit. The mouth, nasal passages, throat and airways are numbed with lidocaine and a thin flexible tube is passed through the nose into the lung airways. Samples of cells and secretions are obtained by rinsing (lavage) the airways with salt water. The fluid is analyzed for infection, inflammatory cells and inflammatory chemicals.\n\nAll infected and exposed individuals will have periodic medical history and physical exam evaluations and be offered treatment or prophylaxis (treatment to prevent infection) with antibiotics, according to the guidelines of the Centers for Disease Control and Prevention (CDC). Patients will be monitored for at least 24 months after antibiotic treatment, or longer if circumstances warrant.\n\nNon-infected, vaccinated individuals\n\n1. medical history and physical examination\n2. blood tests-- between 10 and 50 ml (2-10 teaspoons) of blood will be drawn at a time, and not more than 450 ml will be taken in a 6-week period. Based on the blood test results, other optional research procedures may be requested\n3. leukapheresis to collect white blood cells and plasmapheresis to collect plasma (the liquid part of the blood). For both of these procedures, blood is collected through a needle placed in an arm vein. The blood flows into a special machine that separates it into its components by spinning. The desired components (white cells or plasma) are removed and the rest of the blood is returned to the body through the same needle or a second needle in the other arm.",[25,26],"Anthrax","Bacillus Infections",[25,28,29],"Natural History","Vaccinated Healthy Volunteer","RECRUITING","2026-06-04",{"date":33,"type":34},"2026-06-05","ACTUAL",{"date":36,"type":34},"2002-10-31",{"name":38,"class":39},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":50,"conditions":51,"keywords":52,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"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":49,"type":21},10,"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.",[25],[25,53,54,55,56,57,58],"Bacillus anthracis","Bacterial infection","AIGIV","Anthrax immune globulin","Anti toxin","Polyclonal antibodies","NOT_YET_RECRUITING","2026-02-04",{"date":62,"type":34},"2026-02-06",{"date":64,"type":21},"2026-11-30",{"date":66,"type":21},"2027-08",{"name":68,"class":69},"Emergent BioSolutions","INDUSTRY",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"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":78,"type":21},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.",[25],[25,82,83,84,85,86,87],"Anthrax meningitis","cutaneous anthrax","gastrointestinal anthrax","inhalational anthrax","CYFENDUS","Anthrax vaccine adsorbed adjuvanted","2025-12-04",{"date":90,"type":34},"2025-12-08",{"date":92,"type":21},"2035-11",{"date":94,"type":21},"2037-11",{"name":68,"class":69}]