Trial Information

The Strategy Antifungal Empirical Traditional is Again Justified in Prolonged Neutropenias ". Study "PREVERT"

Patients are eligible if they have an hematologic malignancy, and receive chemotherapy with
an expected neutropenic phase of > 10 days. Patients are randomized according to a 1:1 ratio
to receive either the usual empirical strategy (antifungals are introduced if they have
persistent fever after 4 days of broad-spectrum antibacterials) or the pre-empirical
strategy (administration of antifungals is limited to patients with pneumonia, septic shock,
sinusitis, grade 3 mucositis, aspergillus colonization, liver or splenic abscesses, or
positive galactomannan antigenemia). The antifungals administered are deoxycholate
amphotericin B or liposome amphotericin B, according to the creatinin clearance. This
strategy is applied during the first 14 days of persistent fever, then the therapy is left
at the discretion of the investigator. The primary endpoint is survival at neutrophil
recovery, or, in case of persistent neutropenia, at day 60 at the latest. Secondary
objectives are the incidence of invasive fungal infections (IFI), IFI-free survival, number
of febrile days, and renal function at study completion.