Role of Toxins in Lung Infections Caused by Pseudomonas Aeruginosa

NCT00027183 | Completed

• 2 other identifiers: 98006298-H-0062
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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....

Conditions

Pseudomonas Infection; Cystic Fibrosis

Keywords

Cystic Fibrosis; Effector Proteins; Cytotoxin; Lung Injury; Genetic Screen; Natural History

Outcome Measures

Primary Outcomes (1)

• Serum will be analyzed for the presence of an immune response, focusing on antibodies against the virulence determinants, whilesputum will be analyzed for the immunological and genetic presence of the virulence determinants.

  serum will be analyzed for the presence of an immune response, focusing on antibodies against the virulence determinants, whilesputum will be analyzed for the immunological and genetic presence of the virulence determinants.

  End of Study

Study Arms (2)

1

Healthy Volunteers

2

Cystic Fibrosis subjects

Eligibility Criteria

• Age: 9 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with cystic fibrosis being treated with antibiotics, patients with cystic fibrosis who have not undergone antibiotic therapy, and control patients.@@@@@@

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Finck-Barbancon 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. doi: 10.1046/j.1365-2958.1997.4891851.x.

  PMID: 9302017 BACKGROUND

• 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. doi: 10.1073/pnas.90.6.2320.

  PMID: 8460141 BACKGROUND

• Frank DW. The exoenzyme S regulon of Pseudomonas aeruginosa. Mol Microbiol. 1997 Nov;26(4):621-9. doi: 10.1046/j.1365-2958.1997.6251991.x.

  PMID: 9427393 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Pseudomonas Infections; Cystic Fibrosis; Lung Injury

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Thoracic Injuries; Wounds and Injuries

Study Officials

• Joel Moss, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2001
• First Posted: November 28, 2001
• Study Start: March 17, 1998
• Primary Completion: September 7, 2006
• Study Completion: December 28, 2018
• Last Updated: June 6, 2022

Record last verified: 2022-06

Locations

US (1)