Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201123
Status:
COMPLETED
Last Update Posted:
2016-12-16
First Post:
2005-09-16
Brief Title:
Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Host Response to Tuberculosis and Acquired Immune Deficiency Syndrome
Status:
COMPLETED
Status Verified Date:
2016-12
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:
This study will evaluate the lungs immune response to mycobacterium tuberculosis Mtb infection and will modulate that response with interferon-gamma
Detailed Description:
BACKGROUND
Mtb infects one-third of the worlds population and ranks seventh in terms of global morbidity and mortality Patients with bilateral pulmonary tuberculosis TB cavitary disease and persistently positive sputum smears pose a special risk for treatment failure andor relapse
DESIGN NARRATIVE
Cavitary pulmonary TB will be studied and interferon-gamma will be used as the intervention The outcome of this study will be the changes in mycobacteriology chest radiography and bronchoalveolar lavage BAL cells
The primary outcome will be sputum conversion which will be measured at Weeks 4 and 8
The key secondary outcomes of this study will include a chest computerized tomography CT scan and BAL to measure the flow of cytometry and cytokine levels Both outcomes will be measured at baseline and at Month 4
Mtb infects one-third of the worlds population and ranks seventh in terms of global morbidity and mortality Patients with bilateral pulmonary tuberculosis TB cavitary disease and persistently positive sputum smears pose a special risk for treatment failure andor relapse
DESIGN NARRATIVE
Cavitary pulmonary TB will be studied and interferon-gamma will be used as the intervention The outcome of this study will be the changes in mycobacteriology chest radiography and bronchoalveolar lavage BAL cells
The primary outcome will be sputum conversion which will be measured at Weeks 4 and 8
The key secondary outcomes of this study will include a chest computerized tomography CT scan and BAL to measure the flow of cytometry and cytokine levels Both outcomes will be measured at baseline and at Month 4
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 |
|---|---|---|---|
| R01HL059832-06 | NIH | None | httpsreporternihgovquickSearchR01HL059832-06 |