A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of an Experimental Anti-Fungal versus an FDA-Approved Anti-Fungal for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi

Study Summary

The University of Chicago and Dr. Mullane are conducting a study to compare the overall outcome following study drug administration with an experimental antifungal versus and FDA-approved antifungal in patients with invasive fungal disease caused by Aspergillus species or other filamentous fungi.

Invasive aspergillosis and mucormycosis are difficult to treat with mortality approaching 90 percent in the most severely immunocompromised patients, despite available treatment. Thus, there is an urgent need for potent and safe antifungal agents that can be administered both by mouth (orally) and intravenously (through a vein in the arm).

If you qualify to be in the study and wish to participate, you will be randomly assigned to receive one of the two dosing schemes. Some study subjects will receive the FDA-approved antifungal drug and others will receive the experimental antifungal drug.

In this study, patients will receive treatment up to 84 days and followed up for four weeks after end of treatment. Blood draws are completed four times and at end of study visit four weeks after the end of therapy. The study will last approximately 16 weeks.

Participation Details

• Must be at least 18 years of age
• Must not be pregnant or breastfeeding during the study
• Must be available for clinic visits during duration of study
• Must have a diagnosis of possible, proven or probable invasive aspergillosis.
• Must not have received an antifungal agent for more than four days for the treatment of aspergillosis
• Must meet study medical criteria as evaluated by Dr. Mullane

Study Director: Dr Kate Mullane
Department: Infectious Disease

For more information contact:
Jennifer Theusch
jtheusch@medicine.bsd.uchicago.edu
(773) 702-1665