Protocol Number: 98-H-0062

Title:

Role of Exotoxins in the Pathogenesis of Pseudomonas Aeruginosa

Number:

98-H-0062

Summary:

Some bacteria that cause disease can produce toxic substances that may worsen the disease. Pseudomonas aeruginosa is a bacteria that can produce a variety of toxins and is of special interest for patients with cystic fibrosis and repeated long term lung infections.

The goal of this study is to determine whether specific toxins produced by Pseudomonas aeruginosa may be important in the disease process of chronic lung infections of patients with cystic fibrosis.

This study will attempt to measure bacterial production of toxins in blood and sputum and immune system response to toxins in the blood. Researchers plan to study 4 effector proteins (toxins).

1. exotoxin A

2. Exo S

3. Exo U

4. Pcr V

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA

Patients with cystic fibrosis with a defined mutation in the cystic fibrosis transmembrane regulator (CFTR) (e.g., any of the known variants of the CFTR gene, such as the delta F508 allele).

Patients will have been tested or will be tested for the CFTR gene under another protocol.

Research volunteers that are age-and race-matched as control subjects.

EXCLUSION CRITERIA

Patients who are less than 9 years of age. Research volunteers less than 18 years of age.

Patients or research volunteers who test positive for human immunodeficiency virus (HIV) or a positive serum test for hepatitis B and/or C virus.

Patients or research volunteers who test positive for tuberculosis.

Research volunteers with pulmonary disease or infection.

Special Instructions: Currently Not Provided

Keywords:

Cystic Fibrosis

Effector Proteins

Cytotoxin

Lung Injury

Genetic Screen

Recruitment Keywords:

None

Conditions:

Pseudomonas Infection

Cystic Fibrosis

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

ExoU expression by Pseudomonas aeruginosa correlates with acute cytotoxicity and epithelial injury

The eukaryotic host factor that activates exoenzyme S of Pseudomonas aeruginosa is a member of the 14-3-3 protein family

The exoenzyme S regulon of Pseudomonas aeruginosa

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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