Open, Randomized Comparative Trial of Two Different Schedules of Liposomal Amphotericin B Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of Participants With Invasive Fungal Infection
研究概览
简要总结
The goal of this clinical research study is to compare the effectiveness of liposomal amphotericin B given three times per week , versus liposomal amphotericin B given once per week, versus oral voriconazole in the prevention of fungal infections in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes MDS who are receiving chemotherapy. The safety of these treatments will also be studied and compared.
详细描述
Ambisome and voriconazole are drugs that have been used to fight fungal infections, which typically occur during chemotherapy as a result of lowered immune system functioning. Ambisome works by binding to the sterol component of the fungal cell membrane. This causes "holes" to appear in the membrane, which leads to death of the fungal cell. Voriconazole inhibits an essential step of the biosynthesis of an important component of the fungal cell wall (ergosterol). This causes the impairment of the fungal cell wall.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will be asked questions about your medical history. You will have a complete physical exam and a chest x-ray. You will have computed tomography (CT) scans of the chest. You will also have about 1 teaspoon of blood drawn for routine tests. Test results from the pregnancy test that you will have before your leukemia treatment will be looked at for this study. You will not have a pregnancy test performed for this study.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to one of 3 treatment groups (Group 1, Group 2, or Group 3). Participants in Groups 1 and 2 will receive treatment with ambisome. Participants in Group 3 will receive treatment with voriconazole. Participants in all 3 groups will begin treatment 24 hours after the last dose of chemotherapy.
If you are assigned to Group 1, you will receive ambisome by vein as a continuous infusion over 2 hours 1 time per day, 3 times each week.
If you are assigned to Group 2, you will receive ambisome by vein as a continuous infusion over 2 hours 1 time per week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AML or high risk MDS undergoing induction chemotherapy or first salvage chemotherapy.
- •Age >/=18 years.
- •Patients must sign an informed consent.
排除标准
- •Patients with history of anaphylaxis attributed to azole or amphotericin B compounds.
- •Patients with clinical or other evidence that indicates that they have proven or probable invasive fungal infection prior to enrollment.
- •Patients with total bilirubin levels > 3 times the upper normal limits (i.e. > 3.0 mg/dl); or serum glutamic pyruvic transaminase (SGPT)> 5 times upper limit normal.
- •Patients with serum creatinine > 2.0 mg/dl.
- •Patients receiving any medication that is contraindicated with the use of voriconazole.
- •Patients who have participated in this study during induction chemotherapy.
研究组 & 干预措施
Liposomal amphotericin B: 3 mg/kg
3 mg/kg intravenously (IV) three times per week
干预措施: Liposomal amphotericin B (Drug)
Liposomal amphotericin B: 9 mg/kg
9 mg/kg IV once per week
干预措施: Liposomal amphotericin B (Drug)
Voriconazole: 400 mg
400 mg oral twice daily day 1 followed by 200 mg twice daily
干预措施: Voriconazole (Drug)
结局指标
主要结局
Number of Participants With Invasive Fungal Infection
时间窗: 35 days from the start of therapy for induction participants and 42 days for salvage participants.
Endpoint was whether participant had an invasive fungal infection or not, a potentially fatal complication with leukemia patients. Efficacy defined as absence of proven and probable fungal infection. Probable fungal infection is: 1) Positive radiographic findings consistent with fungal infections documented on CT imaging: Lower respiratory tract infection: halo sign, air crescent-sign, or cavity within areas of consolidation; Sinus: erosion of sinus walls or extension of infection to neighboring structures, extensive skull base destruction; and/or 2) Two positive galactomannan index test.
次要结局
未报告次要终点