An Open Randomised Comparative Multicentre Study of the Efficacy, Safety and Toleration of Voriconazole Versus Amphotericin-B in the Treatment of Acute Invasive Aspergillosis in Immunocompromised Patients
OBJECTIVES: I. Compare the efficacy, safety, and toleration of voriconazole versus
amphotericin B (CAB) in the treatment of acute invasive aspergillosis in immunocompromised
patients. II. Compare the efficacy, safety, and toleration of voriconazole versus CAB
followed by other antifungal therapy in the treatment of acute invasive aspergillosis in
immunocompromised patients. III. Compare survival in patients treated with voriconazole
versus CAB with or without other antifungal therapy. IV. Investigate resource utilization in
patients treated with voriconazole versus CAB with or without other antifungal therapy.
OUTLINE: This is an open label, randomized, multicenter study. Patients are stratified
according to center, site of infection, underlying disease, and baseline neutrophil count.
Patients are randomized to one of two treatment arms. Arm I: Patients receive voriconazole
IV every 12 hours for 7-28 days and continue with oral voriconazole twice a day for a
maximum total duration of 12 weeks of therapy. Arm II: Patients receive intravenous
amphotericin B daily for at least 2 weeks; treatment continues for a maximum of 12 weeks.
Patients discontinued from study drug treatment because of toxicity, intolerance or clinical
failure may receive alternative (nonstudy) antifungal therapy. All patients are monitored
for a total of 16 weeks.
PROJECTED ACCRUAL: A sufficient number of patients will be accrued so that 212 patients (106
per study arm) will be eligible for the study.
Allocation: Randomized, Primary Purpose: Supportive Care
R. Herbrecht, MD
Hopital Universitaire Hautepierre
United States: Federal Government
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