Status:
COMPLETED
Inhalation of Liposomal Amphotericin B to Prevent Invasive Aspergillosis
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Gilead Sciences
Nexstar Pharmaceuticals
Conditions:
Aspergillosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed Description
The morbidity, mortality and costs of invasive pulmonary aspergillosis (IPA) in neutropenic patients are high. An effective intervention to prevent IPA would therefore be welcome. The incidence of IPA...
Eligibility Criteria
Inclusion
- Male or female hospitalized patients aged \> 18 yr
- The patient has a hematologic malignancy or will receive a bone-marrow transplant
- The patient starts with a course of chemotherapy within 4 days or is already neutropenic at admission
- The expected duration of severe neutropenia (PMN\<0.5x10\*9/L) following study entry is \> 10 days
- The patient is receiving oral antibiotic prophylaxis and fluconazole
- Written informed consent has been obtained
Exclusion
- The patient shows evidence of a pulmonary fungal infection or a fungal sinusitis at trial entry
- The concomitant use of systemic anti-aspergillus treatment such as itraconazole or any intravenous formulation of amphotericin B at study entry
- Known hypersensitivity to amphotericin B
- Any evidence of pneumonia or pneumonitis at trial entry
- Any impossibility to use a nebulizer properly
- Expected survival \< 3 months at entry
- Pregnancy
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT00263315
Start Date
January 1 2000
End Date
May 1 2006
Last Update
August 18 2006
Active Locations (2)
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1
Erasmus MC centrumlocatie
Rotterdam, Netherlands
2
Erasmus MC locatie Daniel den Hoed
Rotterdam, Netherlands