A Strategic Study to Determine the Optimal Moment to Initiate Systemic Antifungal Therapy With Ambisome in Granulocytopenic Cancer Patients With Unexplained Fever Refractory to Empirical Antibacterials
- Compare the efficacy and side effects of amphotericin B-liposomal formulation initiated
72-84 hours vs 144-156 hours after onset of a febrile episode in cancer patients with
granulocytopenia and persistent unexplained fever refractory to antibacterials.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
antifungal prophylaxis (yes vs no) and type of underlying condition. Patients are randomized
to 1 of 2 treatment arms.
- Arm I: Patients receive amphotericin B-liposomal formulation IV over 1 hour on day 3 of
- Arm II: Patients receive amphotericin B-liposomal formulation IV over 1 hour on day 6
of febrile neutropenia.
Treatment continues until signs and symptoms of the fungal infection appear or febrile
neutropenia has resolved. Persistently neutropenic patients receive treatment for at least
10 days or until another cause of infection is determined.
Patients are followed weekly for 3 weeks.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Supportive Care
P. Ljungman, MD
United States: Federal Government