ISRCTN64013427已完成不适用
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 leukaemia
niversity Hospital of Cologne (Germany)0 个研究点目标入组 150 人开始时间: 2005年1月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients with first induction chemotherapy for acute myelogenous leukaemia (AML):
- •1. Newly diagnosed or relapsed, de novo or secondary AML
- •2. First induction chemotherapy cycle
- •3. Expected neutropenic phase of a minimum duration of 10 days
- •4. Age greater than 18 years
- •5. Legally signed informed consent
排除标准
- •1. Known proven, probable or possible invasive fungal infection at randomization or in patient history
- •2. CT with any signs of a fungal infection according to the EORTC/MSG criteria, i.e. with any infiltrate (Ascioglu, et al 2002)
- •3. Any current fever unless explained by non-infectious causes
- •4. Antibacterial prophylaxis other than TMP/SMX
- •5. LFT (AST/ALT/bilirubin) more than 3x the upper normal limit
- •6. Subjects who are receiving and cannot discontinue one of the following drugs at least 24 hours prior to randomization:
- •6.1. Drugs with a known possibility of QTc prolongation (e.g. terfenadine, astemizole, cisapride, pimozide, quinidine)
- •6.2. Drugs whose plasma levels may be increased by voriconazole therapy (e.g. sulphonylureas, ergot alkaloids, sirolimus, vinca alkaloids)
- •7. 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)
- •8. Concomitant therapy with absorbable antifungals
- •9. Patient has a diagnosis of acute hepatitis or cirrhosis due to any cause
- •10. Known hypersensitivity or other contraindication to voriconazole
- •11. Patient unwilling or unable to comply with the protocol
- •12. Diseases or disabilities preventing the patient from participating in the trial
- •13. Females of childbearing potential without negative serum pregnancy test at baseline or within 72 hours prior to start of study drug
- •Ascioglu S, Rex JH, de Pauw B, Bennett JE, Bille J, Crokaert F, Denning DW, Donnelly JP, Edwards JE, Erjavec Z, Fiere D, Lortholary O, Maertens J, Meis JF, Patterson TF, Ritter J, Selleslag D, Shah PM, Stevens DA, Walsh TJ; Invasive Fungal Infections Cooperative Group of the European Organization for Research and Treatment of Cancer; Mycoses Study Group of the National Institute of Allergy and Infectious Diseases. Defining opportunistic invasive fungal infections in immunocompromised patients with cancer and hematopoietic stem cell transplants: an international consensus. Clin Infect Dis. 2002 Jan 1;34(1):7-14.
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