Fungal Bioburden and Aspergillosis

Title:  A Prospective, Non-Intervention, Observational Assessment of the Correlation between Circulating Biomarkers of Fungal Bioburden and Clinical Outcome in the Setting of Invasive Aspergillosis
Sponsor:  Merck
PI:  Elias Anaissie, MD 
Phase:  Ib
Purpose:  To evaluate whether the average of the z-scores of the time weighted averages of the serial serum measurements of multiple fungal biomarkers during the initial two weeks of anti-fungal therapy can distinguish between successful clinical outcome and failed clinical outcome at 6 weeks in patients with proven or probable invasive aspergillosis.
Eligibility:  Patient is presumed by study investigator to meet definitions of possible, probable or proven invasive aspergillosis as specified in the revised 2008 criteria developed by the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Co-Operative Group (EORTC/IFICG) and the National Institute of Allergy and Infectious Diseases – Mycoses Study Group (NIAID-MSG).

Approximately 100 male and female patients ?16 years of age with a presumptive diagnosis of possible, probable, or proven invasive Aspergillus infection as defined by EORTC/MSG criteria will be enrolled in the study. Additional patients may be enrolled to ensure a primary analysis population of at least 50 patients.  

Treatment:  The minimum time period that a patient will be enrolled in the study will be approximately 12 weeks following the initiation of anti-fungal therapy. The data collection period may end earlier in the event of patient death. In the case of patient death, pertinent autopsy information, including cause of death, will also be collected if an autopsy is performed. Patients will be assessed for clinical response at 6 and 12 weeks after initiation of anti-fungal therapy.
Contact:   Nathan Petty
501-526-6990 ext. 2435