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NCT00050310 · ClinicalTrials.gov registry record
Natural History of Anthrax: a Study of Primary Infected, Recovered, and Exposed Individuals (SPoRE); and Evaluation of AVA-Vaccinated Recipients
A clinical trial of Anthrax and Bacillus Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- 200
- Enrollment target
- 1
- Study location
NCT00050310 is a study of Anthrax and Bacillus Infections that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 200 participants, below the 745-participant average among 6 other Anthrax trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00050310, a study of Anthrax and Bacillus Infections, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
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 evidence of anthrax * c) nasopharyngeal wash to test for anthrax. Water is sprayed into the nostrils and then allowed to drain for collection in a cup; * 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. * Participants 18
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2002-10-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00050310
The ClinicalTrials.gov registry entry for NCT00050310 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 745-participant average among 6 other Anthrax trials with a reported enrollment target (73% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Anthrax appearing as the primary indexed condition, and to 0 interventions.
NCT00050310 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00050310 about?
NCT00050310 is a clinical study titled "Natural History of Anthrax: a Study of Primary Infected, Recovered, and Exposed Individuals (SPoRE); and Evaluation of AVA-Vaccinated Recipients". 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, no...
What is the current status of trial NCT00050310?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2002-10-31.
What conditions does trial NCT00050310 study?
This clinical trial studies the following conditions: Anthrax, Bacillus Infections.
Who is sponsoring clinical trial NCT00050310?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00050310 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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