CompletedNot Applicable

Role of Toxins in Lung Infections Caused by Pseudomonas Aeruginosa

United States134 participantsStarted 1998-03-17

Plain-language 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....

Who can participate

Age range9 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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.

What they're measuring

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.

Timeframe: End of Study

Trial details

NCT IDNCT00027183

SponsorNational Heart, Lung, and Blood Institute (NHLBI)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2006-09-07