Role of Toxins in Lung Infections Caused by Pseudomonas Aeruginosa
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ClinicalTrials.gov Identifier: NCT00027183 |
Recruitment Status :
Completed
First Posted : November 28, 2001
Last Update Posted : May 25, 2022
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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 or disease |
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Pseudomonas Infection Cystic Fibrosis |
Study Type : | Observational |
Actual Enrollment : | 134 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Role of Exotoxins in the Pathogenesis of Pseudomonas Aeruginosa |
Actual Study Start Date : | March 17, 1998 |

Group/Cohort |
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1
Healthy Volunteers
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2
Cystic Fibrosis subjects
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- 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. [ Time Frame: End of Study ]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.

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Ages Eligible for Study: | 9 Years to 99 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00027183
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | |
Bethesda, Maryland, United States, 20892 |
Principal Investigator: | Joel Moss, M.D. | National Heart, Lung, and Blood Institute (NHLBI) |
Publications:
Responsible Party: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00027183 |
Other Study ID Numbers: |
980062 98-H-0062 |
First Posted: | November 28, 2001 Key Record Dates |
Last Update Posted: | May 25, 2022 |
Last Verified: | October 29, 2021 |
Cystic Fibrosis Effector Proteins Cytotoxin |
Lung Injury Genetic Screen Natural History |
Infections Pseudomonas Infections Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses |