This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
89
Participants will receive aerosol interferon-gamma.
Patients will receive subcutaneous interferon-gamma
NYU School of Medicine
New York, New York, United States
The Lung Institute at University of Cape Town
Cape Town, South Africa
Sputum Conversion
Time frame: Measured at 16 Weeks
Chest Cavity Size
Time frame: 16 Weeks
Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels
Time frame: 16 Weeks
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