NCT00027183|Completed
Role of Toxins in Lung Infections Caused by Pseudomonas Aeruginosa
Role of Exotoxins in the Pathogenesis of Pseudomonas Aeruginosa
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Role of Exotoxins in the Pathogenesis of Pseudomonas Aeruginosa
Sponsor study identifier
Secondary identifiers
observational
134
1 country
1
Study Start
March 17, 1998
Actual (reported)Primary Completion
September 7, 2006
Actual (reported)Study Completion
December 28, 2018
Actual (reported)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....
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 28, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 17, 1998
Actual (reported)November 27, 2001
Actual (reported)November 28, 2001
Actual (reported)September 7, 2006
Actual (reported)December 28, 2018
Actual (reported)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
Healthy Volunteers
Cystic Fibrosis subjects
patients with cystic fibrosis being treated with antibiotics, patients with cystic fibrosis who have not undergone antibiotic therapy, and control patients.@@@@@@
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
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.
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.
Joel Moss, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
134 participants (actual enrollment reported by the registry).
First Submitted
November 27, 2001
First Posted
November 28, 2001
Study Start
March 17, 1998
Actual (reported)A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis
Contact the study team to confirm eligibility.
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.
Primary Completion
September 7, 2006
Actual (reported)Study Completion
December 28, 2018
Actual (reported)Last Updated
June 6, 2022
Record last verified: 2022-06
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