Pharmacokinetic and Deposition Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet®) in Lung Transplant Recipients (Radiotagging Protocol)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- to determine the dose of medication deposited in the lungs
研究概览
简要总结
The purpose of this study is to quantify the dose of aerosol medication deposited in the lungs of lung transplant recipients receiving a single nebulized treatment of aerosolized Abelcet® (lipid complexed amphotericin-B). This study is being performed to determine the range of deposited doses and patterns of distribution that could be expected in this population so that the ultimate efficacy of this preparation can be evaluated. A radioisotope technique will be utilized to track the medication dose. The study will include 12 subjects who will perform one testing session lasting approximately 3 hours. An Investigational New Drug Application (IND) detailing this protocol has been submitted by the principal investigator (PI) and approved by the Food and Drug Administration [FDA] (72,521).
详细描述
Research Methods:
The patient will need to complete one visit that will take about 3 hours of their time. All testing will be performed in the Nuclear Medicine Department located on the first floor of the Presbyterian Hospital.
Screening:
- For women who could possibly be pregnant, a small amount of urine will be used for pregnancy testing to be performed on the study day prior to any drug delivery. Pregnant women, or women who are currently breast-feeding an infant, will not be allowed to take part in this study.
- Patients will be asked a few questions that will not take more than five minutes by one of the investigators or study coordinator. These questions include information about past medical history, surgical dates, medications, etc. The patient's medical record will be reviewed for demographic information (age, sex, and race), lab results (standard post transplant care), medication information, as well as any testing/procedures that they have undergone.
Experimental Procedures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single or double lung transplant recipients
- •Willing to be available at the testing center
- •Able to understand and complete informed consent
排除标准
- •Pregnant women, or women capable of bearing children who will not perform urine pregnancy test.
- •Nursing mothers.
- •Hypersensitivity to amphotericin B (Abelcet®) or technetium [Tc-99m] based radiopharmaceuticals.
- •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 with an FEV1 < 30% predicted or forced vital capacity (FVC) % predicted < 30%
- •Subjects requiring supplemental oxygen
- •Receipt of inhalational or IV amphotericin B within last 30 days
- •Subjects with known fungal infection, as per Mycoses Study Group (MSG) criteria, on therapy with antifungal drugs or diagnosed on the day of bronchoscopy
- •Serum creatinine > 1.9 mg/dl on the day of clinic visit
- •Liver enzymes ALT/AST/alk phos greater than two times the normal limit
- •Concurrent intravenous aminoglycoside use
- •Subjects with fever > 38.2°C
- •Subjects on mechanical ventilation.
- •Have participated in any studies involving radiopharmaceuticals within 14 days.
结局指标
主要结局
to determine the dose of medication deposited in the lungs
次要结局
- to determine the regional distribution of the drug in the lungs