Lung Infection Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Phase II Study of Safety and Efficacy of Inhaled Interferon Gamma-1b With Antimycobacterials in Previously Treated or Mod-to-Sev Pulmonary Mycobacterium Avium Complex Infection
The purpose of this research study is to test the safety and effectiveness of inhaled
Interferon gamma-1b (IFN-g 1b), when administered for 48 weeks and in combination with oral
antibiotics which may be administered for up to 72 weeks for the treatment of a lung
infection caused by a bacterium called Mycobacterium avium complex .
FDA has not approved Interferon gamma-1b for use in patients with MAC infection of the
lungs, which is the purpose of this study.Interferon gamma-1b and similar proteins play
important roles in establishing and maintaining protective immune responses against a
variety of microorganisms.
Laboratory research has shown that a mouse form of interferon gamma is effective in treating mice with infections caused by bacteria similar to MAC as well as MAC infection. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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