NCT00152594终止3 期
Phase III Study of Safety, Tolerance, Efficacy, Pharmacokinetics, and Costs of Therapy With Voriconazole or Placebo in the Prophylaxis of Lung Infiltrates in Patients Undergoing Induction Chemotherapy for Acute Myelogenous Leukemia
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- To determine the incidence of lung infiltrates until day 21 among patients undergoing the first induction chemotherapy for acute myelogenous leukemia who are randomized to prophylactic voriconazole or placebo
研究概览
简要总结
The purpose of the study is to determine whether voriconazole is as effective as antifungal prophylaxis in patients undergoing chemotherapy for acute myelogenous leukemia (AML).
Hypothesis: Voriconazole is superior to placebo in the prophylaxis of lung infiltrates until day 21 after the start of induction chemotherapy.
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
- Double
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
- •Newly diagnosed or relapsed, de novo or secondary AML
- •First induction chemotherapy cycle
- •Expected neutropenic phase of a minimum duration of 10 days
- •Age >= 18 years
- •Legally signed consent form
排除标准
- •Known proven, probable or possible invasive fungal infection at randomization or in patient history
- •Computed tomography (CT) with any signs of a fungal infection according to the European Organisation for the Research and Treatment of Cancer (EORTC)/Mycosis Study Group (MSG) criteria, i.e. with any infiltrate (Ascioglu, et al 2002)
- •Any current fever unless explained by non-infectious causes
- •Antibacterial prophylaxis other than TMP/SMX
- •Liver function test [LFT] (AST/ALT/bilirubin) more than 3x the upper normal limit
- •Subjects who are receiving and cannot discontinue one of the following drugs at least 24 hours prior to randomization:
- •Drugs with a known possibility of QTc prolongation (e.g. terfenadine, astemizole, cisapride, pimozide, quinidine);
- •Drugs whose plasma levels may be increased by voriconazole therapy (e.g. sulfonylureas, ergot alkaloids, sirolimus, vinca alkaloids).
- •Subjects who have received the following drugs within 14 days prior to randomization: potent inducers of hepatic enzymes that will reduce voriconazole levels (e.g. rifampicin, carbamazepine and barbiturates)
- •Concomitant therapy with absorbable antifungals
- •Patient has a diagnosis of acute hepatitis or cirrhosis due to any cause
- •Known hypersensitivity or other contraindication to voriconazole
- •Patient is unwilling or unable to comply with the protocol.
- •Diseases or disabilities preventing the patient from participating in the trial
- •Females of childbearing potential without negative serum pregnancy test at baseline or within 72 hours prior to start of study drug
结局指标
主要结局
To determine the incidence of lung infiltrates until day 21 among patients undergoing the first induction chemotherapy for acute myelogenous leukemia who are randomized to prophylactic voriconazole or placebo
次要结局
- To determine and compare between study arms the: incidence of fever and other signs of infection
- incidence and type of documented bacteremia
- rate of patients with systemic open-label antifungal therapy
- time to initiation of systemic open-label antifungal therapy
- duration of absolute neutrophil count < 500/µl
- rate and type of proven, probable and possible breakthrough invasive fungal infections
- rate of patients with fever of unknown origin
- incidence and severity of adverse events
- trough voriconazole plasma level after day 8 of study treatment
- direct costs of systemic antibiotics, antifungals and antivirals and diagnostic imaging
- overall costs in terms of the diagnosis related groups applied to the study patients
研究者
研究点 (6)
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