EICHORCondition: Anthrax · Bacillus Infections · Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Interested? Contact the study team ↓
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
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. The following individuals may be eligible for this study: 1. People with confirmed or suspected anthrax (inhalational, cutaneous or gastrointestinal, either acute or recovering); 2. People exposed to anthrax who have no clinical symptoms. 3. Healthy people who have not been exposed to anthrax and have been vaccinated with AVA. Those enrolled in the study will undergo the following tests and procedures. Infected and exposed individuals: * Symptomatic participants will have the following clinical procedures if medically necessary: * a) blood tests for cell counts, chemistries and evidence of anthrax bacteria; * b) nasal swab to test for evidence of anthrax * c) chest X-ray; * d) computed tomography (CT) scan (special X-rays to examine the lungs or abdomen); * e) echocardiogram to examine the heart * 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. * All subjects (with or without symptoms) will have the following research procedures: * a) blood tests to examine immune response to anthrax; * b) throat swab to test for e…
This description comes directly from the study's public registry record.
Rosemary McConnell, R.N. · (301) 312-1235 · rosemary.mcconnell@nih.gov
Mary E Wright, M.D. · (301) 594-6318 · marywright@mail.nih.gov
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
* INCLUSION CRITERIA: Subjects 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. Although 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. Decisionally 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. 1. Inhalation Anthrax (acute or recovering infection) CONFIRMED: --nonspecific febrile illness followed by sepsis and/or respiratory failure AND --B anthracis isolation (via culture) from any site OR 2 supportive lab tests OR SUSPECTED: --nonspecific febrile illness followed by sepsis and/or respiratory failure with no alternative diagnosis AND --one supportive lab test OR direct epidemiological link to a confirmed environmental exposure 2. Cutaneous Anthrax (acute or recovering infection) CONFIRMED: --characteristic lesion (papule-\>vesicular-\>depressed black eschar plus or minus edema, erythema, necrosis, or ulceration) AND --B anthracis isolation (culture) from any site OR 2 supportive lab tests SUSPECTED: --Characteristic lesion with no alternative diagnosis AND --one supportive lab test OR direct epidemiological link to a confirmed environmental exposure 3. Gastrointestinal Anthrax (acute or recovering infection) CONFIRMED: --Severe abdominal pain often associated with bloody vomiting/diarrhea followed by fever/septicemia AND --B anthracis isolation (culture) from any site OR 2 supportive lab tests SUSPECTED: --Severe abdominal pain often associated with bloody vomiting/diarrhea followed by fever/septicemia with no alternative diagnosis AND --1 supportive lab test OR direct epidemiological link to a confirmed environmental exposure 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). 4. Exposed individuals who are clinically asymptomatic. 5. Past or imminent vaccination in healthy (non-anthrax exposed). 6. Hemodynamically and clinically stable at time of evaluation at NIH. * Hemodynamically: stable vital signs * Clinically: no obvious signs of disease progression (e.g. worsening pleural effusions or increasing cutaneous edema) * acute/newly recovered patients must be receiving standard antimicrobial therapy 7. Participant agrees to stored samples. EXCLUSION CRITERIA: Inability of subject or Legally Authorized Representative (LAR) to understand or subject not willing to sign a written informed consent document.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| National Institutes of Health Clinical Center | Bethesda, Maryland, United States | Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT00050310