A Prospective, Randomized Trial Comparing the Efficacy of an Experimental (Not Approved by the FDA) Anti-Fungal and an FDA-Approved Anti-Fungal in Combination to that of the FDA-Approved Anti-Fungal Alone When Used for Primary Therapy of Proven or Probable Invasive Aspergillosis

Study Summary

The University of Chicago and Dr. Mullane are conducting a study to compare the effectiveness of the drug in patients receiving an experimental anti-fungal and an FDA-approved anti-fungal in combination to that of the approved anti-fungal alone for the treatment of patients with invasive Aspergillosis (fungus).

Invasive aspergillosis (IA) is an important cause of morbidity and mortality in patients with hematological malignancies, as well as those who have undergone allogeneic hematopoietic stem cell transplantation (HSCT).

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 anti-fungal plus the experimental anti-fungal and others will receive the FDA-approved anti-fungal plus placebo.

In this study, patients will receive six weeks of study drug administration with weekly visits and blood draws and an end of study visit six weeks after the end of study drug administration. The study will last approximately 12 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 have received an allogeneic stem cell transplant or have a hematological malignancy and is not responding to treatment
• Must not have received an anti-fungal 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

IRB: #15962A