Overview

PROPHYSOME: Pilot Study on Safety of a Weekly Administration of 10mg/kg of AmBisome® in Antifungal Prophylaxis Treatment of Allogeneic Stem-cell Transplantation and Acute Leukaemia

Status:
Completed

Trial end date:
2006-03-01

Target enrollment:

Participant gender:

Summary

This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome loading dose regimen, in a weekly administration schedule, during the aplastic phase following induction or consolidation chemotherapy for acute leukaemia, and during the initial phase of allogeneic stem-cell transplant, which are both high risk periods as far as severe fungal infections development is concerned.

Phase:

Phase 4

Details

Lead Sponsor:

Gilead Sciences

Treatments:

Amphotericin B
Antifungal Agents
Liposomal amphotericin B
Miconazole