Expression of Tuberculosis in the Lung
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00201253|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : January 26, 2015
|Condition or disease||Intervention/treatment|
|Tuberculosis||Other: Bronchoalveolar lavages and venipunctures only|
M. tuberculosis infects a third of the world's population, and TB is the leading cause of morbidity and mortality due to a single infectious agent. However, only 5% to 10% of M. tuberculosis-infected subjects without an underlying immunodeficiency develop disease during their lifetimes. Therefore protective immunity is induced in the majority of subjects. Understanding correlates of protection against M. tuberculosis in humans is needed to better direct efforts in the development of antituberculosis vaccines.
Patients are treated according to good clinical practice; however, no study medications are given as part of the research study. This study involves a one-time bronchoalveolar lavage and venipuncture to obtain immune cells for laboratory studies of immune responses.
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Observational Model:||Case Control|
|Official Title:||Expression of Tuberculosis in the Lung|
|Study Start Date :||September 2000|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
- Pulmonary immune responses associated with resistance and susceptibility to Mycobacterium tuberculosis infection (measured at baseline) [ Time Frame: one week ]
Biospecimen Retention: Samples With DNA
Cell culture supernatants and cell lysates from bronchoalveolar cells, as well as peripheral blood mononuclear cells.
Bronchoalveolar lavage fluid
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): NCT00201253
|United States, New Jersey|
|UMDNJ-New Jersey Medical School|
|Newark, New Jersey, United States, 07103|
|Instituto Nacional de Enfermedades Respiratorias (INER)|
|Mexico City, Mexico|
|Principal Investigator:||Jerrold Ellner||UMDNJ-New Jersey Medical School|