Nebulized Liposomal Amphotericin B (Ambisome) Versus Nebulized Placebo for the Prophylaxis of Invasive Pulmonary Aspergillosis in Haematological Patients With Prolonged Neutropenia. A Randomized Clinical Trial.

NCT00263315 Phase 2/Phase 3 COMPLETED

A Phase II/III randomized double-blind study comparing the safety and the efficacy of a weekly administration of 25 mg nebulized AmBisome with nebulized placebo solution to prevent invasive pulmonary aspergillosis in neutropenic hemato-oncologic patients.

Details

Lead sponsor	Erasmus Medical Center
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	320
Start date	2000-01
Completion	2006-05

Conditions

• Aspergillosis

Interventions

• nebulised liposomal amphotericin B

Primary outcomes

• SAFETY: Discontinuation for >1week due to intolerance
• EFFICACY: Proven/probable invasive pulmonary aspergillosis

Countries

Netherlands