Inhalation of Liposomal Amphotericin B to Prevent Invasive Aspergillosis

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Collaborators: Gilead Sciences; Nexstar Pharmaceuticals
• Treatments: Amphotericin B; Liposomal amphotericin B

Criteria

Inclusion Criteria:

1. Male or female hospitalized patients aged > 18 yr

2. The patient has a hematologic malignancy or will receive a bone-marrow transplant

3. The patient starts with a course of chemotherapy within 4 days or is already neutropenic at admission

4. The expected duration of severe neutropenia (PMN<0.5x10*9/L) following study entry is > 10 days

5. The patient is receiving oral antibiotic prophylaxis and fluconazole

6. Written informed consent has been obtained

Exclusion Criteria:

1. The patient shows evidence of a pulmonary fungal infection or a fungal sinusitis at trial entry

2. The concomitant use of systemic anti-aspergillus treatment such as itraconazole or any intravenous formulation of amphotericin B at study entry

3. Known hypersensitivity to amphotericin B

4. Any evidence of pneumonia or pneumonitis at trial entry

5. Any impossibility to use a nebulizer properly

6. Expected survival < 3 months at entry

7. Pregnancy