Galactomannan antigenemia as a biomarker for therapeutic response of invasive aspergillosis: implications for clinical trial design and patient care.

BACKGROUND

Clinical trials for invasive pulmonary aspergillosis, a potentially lethal mold infection, are complex investigations that require protracted time and extensive resources, delaying the development of new antifungal agents for this important disease. Areas covered: In this paper, the authors examine a novel approach to study invasive pulmonary aspergillosis in humans, with a focus on the potentials and pitfalls of surrogate end points such as galactomannan antigenemia to evaluate therapeutic response to novel compounds. Expert commentary: The authors believe the use of serum galactomannan as a primary end point in clinical trials may allow for development studies that could be accomplished with fewer resources. It is widely appreciated that serum galactomannan values strongly correlate with outcome of invasive aspergillosis in patients with hematologic cancer and may be applicable to other at-risk patient populations.