NCT00811928已完成3 期
A Randomized, Open Label Parallel Controlled, Multicenter Study to Evaluate Safety and Efficacy of Posaconazole Oral Suspension Vs. Fluconazole (Capsule) in High-risk Leukopenic Patients for Prevention of Invasive Fungal Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 252
- 主要终点
- Number of Participants With Proven or Probable Diagnosis of Invasive Fungal Infection (IFI) During the Treatment Period
研究概览
简要总结
A randomized, open label parallel controlled, multicenter study to evaluate safety and efficacy of Posaconazole oral suspension vs Fluconazole (capsule) in high-risk leukopenic patients for prevention of invasive fungal infection
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be 18-70 years of age of either sex
- •Persistent neutropenia (Absolute Neutrophil Count [ANC] < 500/mm^3 [0.5x10^9/L]）or probable neutropenia in 3-5 days is anticipated. Neutropenia >= 7 days caused by the following reasons
- •Standard or dose-intense chemotherapy, anthracyclines or other acceptable chemotherapies ( any investigational drug is not permitted) for Acute Myelogenous Leukemia (AML) treatment
- •Retreatment of chemotherapy in case of AML recurrence
- •Myelodysplastic syndrome (MDS) shifts to AML and bone marrow arrest induction chemotherapy is required (not including acute phase of chronic myelogenous leukemia [CML])
- •Informed consent obtained from participant or legal guardian
排除标准
- •Participants previously treated with amphotericin B (AMB), fluconazole (FLZ), or itraconazole (ITZ) within 30 days of enrollment.
- •Participants who have taken the following drugs:
- •terfenadine, cisapride, and ebastine within 24 hours before entry
- •astemizole at entry or within 10 days before entry
- •cimetidine, rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, isoniazid atharanthine and anthracyclines within 24 hours before entry
- •The above drugs are refrained during the investigation
- •Serious organ diseases except hematological disorder such as cardiac or neurologic disorders or impairment expected to be unstable or progressive during the course of this study (eg, seizures or demyelinating syndromes, acute myocardial infarction within 3 months of study entry, myocardial ischemia, congestive heart failure, atrial fibrillation with ventricular rate <60/min, or history of torsades de pointes, symptomatic ventricular or sustained arrhythmias), unstable electrolyte abnormalities.
- •Participants who have used any investigational drugs or biologic agents other than their chemotherapy regimens within 30 days of study entry.
- •Prior enrollment in this study.
- •Participants with known or suspected hypersensitivity or idiosyncratic reaction to azole agents or amphotericin B.
- •Participants with known or suspected invasive fungal infection (IFI) at screen
- •Participants with severe renal insufficiency (estimated creatinine clearance less than 50 mL/minute or likely to require dialysis during the study), Alanine transaminase (ALT), Aspartate transaminase (AST), alkaline phosphatase or total bilirubin are >2× (Upper Limit of Normal) ULN.
- •Participants having an electrocardiogram (ECG) with a prolonged QTc interval: QTc greater than 450 msec for men and greater than 470 msec for women.
- •Participants with AML or CML history.
- •Participants with a history of allogeneic hematopoietic stem cell, bone marrow transplantation, autologous stem cell transplantation history.
- •Female participants who are pregnant or are nursing.
- •Alcohol and/or drug abuse.
- •Participants cannot be compliant in the opinion of the investigator.
研究组 & 干预措施
Posaconazole
Active Comparator
Posaconazole oral suspension 200 mg three times a day (TID)
干预措施: Posaconazole (Drug)
Fluconazole
Active Comparator
Fluconazole 400 mg once daily (QD)
干预措施: Fluconazole (Drug)
结局指标
主要结局
Number of Participants With Proven or Probable Diagnosis of Invasive Fungal Infection (IFI) During the Treatment Period
时间窗: Up to 12 Weeks (84 days) plus 7 days
Number of participants developing a proven or probable IFI from randomization to the last dosage date (up to 12 weeks \[84 days\]) plus 7 days. IFI diagnosis criteria may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, microbiological criteria with corresponding clinical signs and symptoms.
次要结局
- Time From Randomization to Administration of First Systemic Antifungal Intravenous (IV) Therapy(Up to 12 weeks (84 days))
- Number of Participants With Clinical Failure During Treatment(Up to 12 weeks (84 days))
- Number of Participants in Whom All-cause Mortality Occurred Within 100 Days From Randomization(Randomization date to Day 100)
- Number of Participants in Whom Mortality is Unlikely, Possibly, and Probably Related to Fungal Infection Occurred Within 100 Days From Randomization(From randomization date to Day 100)
- Number of Participants With Proven or Probable Diagnosis of IFI Within 100 Days From Randomization(From randomization date to Day 100)
- Time From Randomization to the First Onset of Proven or Probable IFI(From randomization date to Day 100)
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