Ensayos clínicos

Inclusion Criteria:

1. Male and female patients ages over 18 years and weighing more than 40 kg

2. Patients with proven IA at any site or probable LRTD IA per EORTC/MSG 2019 criteria as
adapted for this study

3. Patients requiring therapy with an antifungal agent other than a mould-active azole on
the basis of IA refractory to mould-active azole therapy, proven resistance to the
mould active azoles, breakthrough infection on mould-active triazole prophylaxis, or
azole drug-drug interactions (or potential for drug-drug interactions).

4. AmBisome® is an appropriate therapy for the patient.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.

2. Known history of allergy, hypersensitivity, or any serious reaction to any component
of the study drug

3. Patients with only chronic aspergillosis, aspergilloma, or allergic bronchopulmonary
aspergillosis.

4. Suspected mucormycosis (zygomycosis).

5. Patients with a known active second fungal infection of any type, other than
candidiasis that can be treated with fluconazole.

6. The use of an echinocandin as Candida prophylaxis.

7. Microbiological findings (eg, bacteriological, virological) or other potential
conditions that are temporally related and suggest a different aetiology for the
clinical features.

8. Human immunodeficiency virus (HIV) infection but not currently receiving
antiretroviral therapy.

9. Patients with a baseline prolongation of QT using Fridericia's Correction Formula
(QTcF) ≥ 500 msec, or at high risk for QT/QTc prolongation.

10. Evidence of hepatic dysfunction.