Status:
COMPLETED
Nebulized Liposomal Amphotericin B Ambisome for Prophylaxis of Invasive Pulmonary Aspergillosis
Lead Sponsor:
PETHEMA Foundation
Conditions:
Acute Myeloid Leukemia
Allogeneic Haematopoietic Progenitor Cell Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The trial is planned as a multicentric, national, phase II, open-label trial to evaluate safety and tolerance of nebulized Liposomal Amphotericin B (Ambisome) for LMA patients during the induction the...
Detailed Description
The invasive fungal infection (IFI) is the most common cause of mortality related to autologous stem cell transplant. Taking into account that Saprophytic Aspergillus is usually acquired by inhalation...
Eligibility Criteria
Inclusion
- Patient has decided voluntary to consent his or her participation signing the consent form before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Patients with Acute myeloid Leukemia (AML), that will start induction chemotherapy or those patients submitted to an Allogeneic haematopoietic progenitor cell transplant.
- The patient is \>18 years old.
Exclusion
- Patient with prior Invasive Pulmonary Aspergillosis (IPA) history.
- History of allergy or hypersensitivity to Amphotericin B.
- Patient with intellectual deficit or patients with psychological alterations that make impossible the trial understanding.
- Pregnancy or breastfeeding.
- Patient has received other investigational drug or non traded product within 30 days before trial beginning.
- Patient is enrolled in another clinical research study or/and is receiving an investigational agent for any reason.
- Patient had major surgery within 4 weeks before enrollment.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00391014
Start Date
January 1 2006
End Date
April 1 2009
Last Update
May 12 2009
Active Locations (4)
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1
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
2
Hospital Universitario de la Princesa
Madrid, Madrid, Spain
3
Hospital Universitario la Fe
Valencia, Valencia, Spain
4
Hospital Universitario de Salamanca
Salamanca, Spain