Status:
SUSPENDED
Safety and Efficacy Study of Inhaled AmBisome for Prevention of Aspergillus Colonization in Lung Transplant Recipients
Lead Sponsor:
University Health Network, Toronto
Conditions:
Lung Transplant Recipient
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 assoc...
Detailed Description
In this pilot study, our main aims are: 1. To determine the safety of once weekly Inhaled AmBisome prophylaxis in preventing the development of Aspergillus colonization in lung transplant recipients ...
Eligibility Criteria
Inclusion
- Single or double lung transplant recipients who are at least one year out of transplantation.
- Age \>18yrs of age
- Able to understand and complete informed consent.
Exclusion
- Pregnant woman or woman capable of bearing children, who will not perform urine pregnancy test.
- Nursing mothers.
- Subjects with hypersensitivity to Amphotericin deoxycholate or liposomal Amphotericin.
- Subjects with a past history of bronchospasm associated with aerosol drug use.
- Subjects with active bacterial or viral infection as defined by the current use of non-prophylactic antibiotic anti-viral medications.
- Subjects treated with cytolytic medications (Campath /Thymoglobulin) within the last month.
- Subjects with an FEV1\< 30% Predicted or FVC% \<30%.
- Subjects requiring supplemental oxygen.
- Receipt of Inhaled or IV Amphotericin B within last 30 days.
- Subjects with known fungal infection as per MSG Criteria on therapy with antifungal drugs or diagnosed on the day of bronchoscopy.
- Current use of azoles active against molds (Voriconazole, itraconazole, posaconazole) for the prophylaxis.
- Serum creatinine \> 150 mmol/L on the day of clinic visit.
- Liver enzymes ALT/ AST/ Alkphos greater than two times upper limit of normal.
- Concurrent intravenous aminoglycoside use.
- Subjects with fever \> 38.2°C.
- Subjects on mechanical ventilation.
- Expected survival less than 6 months.
- Re-transplants and heart/lung transplant patients.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2014
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01254708
Start Date
January 1 2012
End Date
January 1 2014
Last Update
October 19 2011
Active Locations (1)
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1
University Health Network/ Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2