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Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs

2014-07-23 21:48:07 | BioPortfolio

Summary

This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.

Description

BACKGROUND:

Mtb infects one-third of the world's 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 and/or 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 Design

Allocation: Randomized, Primary Purpose: Treatment

Conditions

Tuberculosis

Intervention

IRPE Anti-Tuberculous Therapy, Aerosol Interferon-Gamma, Subcutaneous Interferon-Gamma

Location

NYU School of Medicine
New York
New York
United States
10016

Status

Active, not recruiting

Source

National Heart, Lung, and Blood Institute (NHLBI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:48:07-0400

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An interferon regulatory factor that recruits STAT1 PROTEIN and STAT2 PROTEIN heterodimers to interferon-stimulated response elements and functions as an immediate-early protein.

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