Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201253
Status:
COMPLETED
Last Update Posted:
2015-01-26
First Post:
2005-09-16
Brief Title:
Expression of Tuberculosis in the Lung
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Expression of Tuberculosis in the Lung
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess lung immune responses in patients with active pulmonary tuberculosis TB and in healthy control persons who are exposed to Mycobacterium tuberculosis in households of patients with TB or who are unexposed
Detailed Description:
BACKGROUND
M tuberculosis infects a third of the worlds 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
DESIGN NARRATIVE
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
M tuberculosis infects a third of the worlds 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
DESIGN NARRATIVE
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL051630 | NIH | None | httpsreporternihgovquickSearchR01HL051630 |