Clinical Trial: Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Host Response to Tuberculosis and Acquired Immune Deficiency Syndrome
Brief Summary: This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.
Detailed Summary:
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.
Sponsor: New York University School of Medicine
Current Primary Outcome: Sputum Conversion [ Time Frame: Measured at 16 Weeks ]
Original Primary Outcome:
Current Secondary Outcome:
- Chest Cavity Size [ Time Frame: 16 Weeks ]
- Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels [ Time Frame: 16 Weeks ]
Original Secondary Outcome:
Information By: New York University School of Medicine
Dates:
Date Received: September 16, 2005
Date Started: April 2005
Date Completion:
Last Updated: December 14, 2016
Last Verified: December 2016
