Role of Toxins in Lung Infections Caused by Pseudomonas Aeruginosa

This study has suspended participant recruitment.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ) Identifier:
First received: November 27, 2001
Last updated: March 21, 2015
Last verified: March 2014

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.

Pseudomonas Infection
Cystic Fibrosis

Study Type: Observational
Official Title: Role of Exotoxins in the Pathogenesis of Pseudomonas Aeruginosa

Resource links provided by NLM:

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

Enrollment: 134
Study Start Date: February 1998
Detailed Description:

The goal of this study is to determine whether virulence determinants that use the type III-secretory pathway may be important in the pathogenesis of chronic Pseudomonas aeruginosa lung infections in patients with cystic fibrosis (CF). The studies will quantify bacterial effector proteins in serum and sputum and the immune response to specific products as reflected by antibodies in serum. Candidate effector proteins include: (1) exotoxin A, a non-type III-dependent ADP-ribosyltransferase and cytotoxin that does not use the Type III secretory pathway, (2) ExoS, a type III pathway-dependent extracellular ADP-ribosyltransferase with cytotoxic activity, (3) ExoU, another type III-dependent cytotoxin, that is responsible for epithelial injury in acute lung infections, and (4) PcrV, a homolog to the V antigen of Yersinia.


Ages Eligible for Study:   9 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.


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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00027183

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
United States, Washington
University of Washington - Cystic Fibrosis Center
Seattle, Washington, United States, 98195
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Principal Investigator: Joel Moss, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ) Identifier: NCT00027183     History of Changes
Other Study ID Numbers: 980062, 98-H-0062
Study First Received: November 27, 2001
Last Updated: March 21, 2015
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cystic Fibrosis
Effector Proteins
Lung Injury
Genetic Screen

Additional relevant MeSH terms:
Cystic Fibrosis
Pseudomonas Infections
Bacterial Infections
Digestive System Diseases
Genetic Diseases, Inborn
Gram-Negative Bacterial Infections
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Respiratory Tract Diseases processed this record on March 26, 2015