Role of Toxins in Lung Infections Caused by Pseudomonas Aeruginosa

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2016 by National Institutes of Health Clinical Center (CC)

Sponsor:

Information provided by (Responsible Party):

National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

ClinicalTrials.gov Identifier:

NCT00027183

First received: November 27, 2001

Last updated: August 31, 2016

Last verified: August 2016

History of Changes

Purpose

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.

Condition
Pseudomonas Infection Cystic Fibrosis


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

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Pseudomonas aeruginosa

Genetic and Rare Diseases Information Center resources: Cystic Fibrosis

U.S. FDA Resources

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


Estimated Enrollment:	225
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.

Eligibility


Ages Eligible for Study:	9 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

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 ClinicalTrials.gov identifier: NCT00027183

Contacts


Contact: Mary Haughey, R.N.	(301) 496-3632	mhaughey@nhlbi.nih.gov
Contact: Joel Moss, M.D.	(301) 496-1597	mossj@nhlbi.nih.gov

Locations


United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators


Principal Investigator:	Joel Moss, M.D.	National Heart, Lung, and Blood Institute (NHLBI)

More Information

Additional Information:

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

Publications:

Finck-Barbançon V, Goranson J, Zhu L, Sawa T, Wiener-Kronish JP, Fleiszig SM, Wu C, Mende-Mueller L, Frank DW. ExoU expression by Pseudomonas aeruginosa correlates with acute cytotoxicity and epithelial injury. Mol Microbiol. 1997 Aug;25(3):547-57.

Fu H, Coburn J, Collier RJ. The eukaryotic host factor that activates exoenzyme S of Pseudomonas aeruginosa is a member of the 14-3-3 protein family. Proc Natl Acad Sci U S A. 1993 Mar 15;90(6):2320-4.

Frank DW. The exoenzyme S regulon of Pseudomonas aeruginosa. Mol Microbiol. 1997 Nov;26(4):621-9. Review.


Responsible Party:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00027183 History of Changes
Other Study ID Numbers:	980062 98-H-0062
Study First Received:	November 27, 2001
Last Updated:	August 31, 2016
Health Authority:	United States: Federal Government

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


Cystic Fibrosis Effector Proteins Cytotoxin Lung Injury Genetic Screen

Additional relevant MeSH terms:


Infection Fibrosis Cystic Fibrosis Pseudomonas Infections Pathologic Processes Pancreatic Diseases Digestive System Diseases	Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Gram-Negative Bacterial Infections Bacterial Infections

ClinicalTrials.gov processed this record on September 23, 2016

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