Design of efficacy trials of cytokines in combination with antifungal drugs

Resolution of invasive fungal infections is often dependent on recovery from an immunocompromised state, which indicates that host defense mechanisms are extremely important in the clearance of fungal pathogens. Immunotherapy aimed at enhancement of host defense mechanisms may improve clinical outcome of invasive mycoses. The design of trials of immunotherapy against fungal pathogens requires profound knowledge of the host defense mechanisms that are involved in invasive fungal infections. Prospective phase II studies with recombinant granulocyte colony-stimulating factor and interferon-g have been done. Recombinant interferon-g is a candidate for phase III trials of adjunctive immunotherapy for cryptococcal meningitis, invasive as-pergillosis, and candidemia, but the proper design of future trials will be crucial to establish whether im-munotherapy is of clinical value in the treatment of invasive fungal infections. Recently, great progress has been made in the devel-opment of antifungal therapy. New classes of antifungal drugs have been introduced that show promise for achieving cure from infection and a lower incidence of adverse effects [1–3]. For patients with invasive asper-gillosis, therapy with voriconazole—a new triazole an