Natural History of Anthrax: a Study of Primary Infected, Recovered, and Exposed Individuals (SPoRE); and Evaluation of AVA-Vaccinated Recipients - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00050310

Purpose

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:

People with confirmed or suspected anthrax (inhalational, cutaneous or gastrointestinal, either acute or recovering);
People exposed to anthrax who have no clinical symptoms.
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 years of age and older may have the following optional research procedures:
a) leukapheresis or plasmapheresis (see description under non-infected, vaccinated individuals above);
b) lymph node biopsy. A sample of lymph node tissue is surgically removed under local anesthetic;
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.

All 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.

Non-infected, vaccinated individuals

medical history and physical examination
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
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.

Condition
Anthrax

Study Type:	Observational
Study Design:	Prospective
Official Title:	Natural History of Anthrax: A Study of Primary Infected, Recovered, and Exposed (SPoRE) Individuals and Evaluation of AVA Vaccinated Recipients

Resource links provided by NLM:

MedlinePlus related topics: Anthrax

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	200
Study Start Date:	February 2002

Detailed Description:

The intentional use of Bacillus anthracis as a bioterrorism weapon with fatal consequences has renewed interest in past epidemiological and animal research about pathogenesis and posed new dilemmas about diagnosis and treatment. Cases in the October 2001 US outbreak were theoretically exposed via the same dispersal method: aerosolization of chemically treated Ames strain spores. While some developed the cutaneous form, others sustained the more serious inhalational disease. Inhaled spores are known to travel to alveolar macrophages and then onto the mediastinal lymph nodes where germination to the bacterium form and toxin release are thought to occur. Infective dose, significance of dormant spores after long-term antibiotic therapy, spectrum of disease and even precise cause of death remain unknown. In this observational, prospective natural history study, participants at various stages of disease or exposure will be followed for at least two years. Persons with acute and resolving disease will undergo laboratory, microbiological, and imaging testing at regular time points and receive standard antimicrobial therapy. In the setting of potential acute exposure, individuals with positive nasal swabs for Bacillus anthracis will be assessed in a similar fashion. Healthy vaccinated participants may also be included to evaluate serum titers in relation to dose and frequency of AVA vaccine.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

Subjects of any age, 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.

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
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
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
Exposed individuals who are clinically asymptomatic.
Past or imminent vaccination in healthy (non-anthrax exposed).
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
Participant agrees to stored samples.

EXCLUSION CRITERIA:

Inability to sign informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050310

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Dalton R. Genetic sleuths rush to identify anthrax strains in mail attacks. Nature. 2001 Oct 18;413(6857):657-8. No abstract available.

Shafazand S, Doyle R, Ruoss S, Weinacker A, Raffin TA. Inhalational anthrax: epidemiology, diagnosis, and management. Chest. 1999 Nov;116(5):1369-76. Review.

[No authors listed] Update: Investigation of bioterrorism-related anthrax and adverse events from antimicrobial prophylaxis. MMWR Morb Mortal Wkly Rep. 2001 Nov 9;50(44):973-6.

Study ID Numbers:	020110, 02-I-0110
Study First Received:	December 3, 2002
Last Updated:	January 6, 2010
ClinicalTrials.gov Identifier:	NCT00050310 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Confirmed
Suspected
Pathogenesis
Bronchoscopy

Cultures
Anthrax
Natural History
Vaccinated Healthy Volunteer

Additional relevant MeSH terms:

Bacterial Infections
Gram-Positive Bacterial Infections
Bacillaceae Infections
Anthrax

ClinicalTrials.gov processed this record on February 08, 2010