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Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B in Lung Transplant Recipients
NCT00177684Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2004
- Countries
- 1
- Sponsor
- University of Pittsburgh
- Modality
- Small Molecules
- Drugs
- amphotericin b
- Conditions
- invasive aspergillosis (IA)
01
Overview
Phase 3, open-label, single-arm trial of amphotericin b in invasive aspergillosis (IA), sponsored by University of Pittsburgh. Primary endpoint: Optimal delivery system for nebulization. Started Sep 2004; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Amphotericin B Nebulization
Aerosolized liposomal amphotericin B administered daily for 4 days.
03
Who it enrols
Male and female lung transplant recipients >= 18 years old. Excludes pregnant/breastfeeding women, patients with a documented fungal infection, recent use of amphotericin B, fever >= 38ºC, hypoxemia, or those on a mechanical ventilator.
04
Endpoints
Primary
Optimal delivery system for nebulization
Secondary
Concentrations of amphotericin B in epithelial lining fluid and serum
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