Safety and Efficacy Study of Inhaled AmBisome for Prevention of Aspergillus Colonization in Lung Transplant Recipients
Status:
Suspended
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
Lung transplant recipients have the highest rate of Invasive Aspergillus (IA)infection among
solid organ transplant recipients. The most important risk factor for the development of IA
(which is associated with disease and death) is colonization of the organism in the
respiratory tract.
Azoles are used to prevent the development of IA. Puffers containing antifungal medication
can be used to treat the lungs without the need to worry about the medication interactions &
side-effects in the blood. An example of this is the aerosolized amphotericin B. Its use is
limited by the patients' tolerating this medication that may cause cough, nausea &
contraction of the air pathways.
The lipid preparation is better tolerated and has longer dosing interval than inhaled
amphotericin B. The investigators propose a pilot study to determine the long-term safety of
inhaled AmBisome administration of drug and generate the preliminary data on the
effectiveness of this drug to prevent aspergillus colonization.