Efficiency of Antibacterial Prophylaxis (Levofloxacin) in Azacitidine Treated Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Febrile episode occurrence
研究概览
简要总结
Infections are a major life-threatening complication in patients with myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML). Currently there is no guidelines about antibacterial prophylaxis to prevent infections in patients with myelodysplastic syndrome or acute myeloid leukaemia. The investigators will conduct a randomized prospective study to evaluate the benefit of prophylactic antibacterial by levofloxacin on febrile episode in Azacytidine treated patients (MDS and AML).
详细描述
This is a randomized prospective study with 2 arms to evaluate the efficacy of Levofloxacin prophylaxis in Azacytidine treated patients (MDS and AML) Levofloxacin will be given 500mg/d p.o. for the first three cycles of Azacytidine in patients randomized in arm antibacterial prophylaxis. In control arm patients will not received levofloxacin.
The expected duration of subject participation is one year after randomization.
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
- •Age superior to 18 years old
- •SMD or AML treated with azacytidine (not previously treated)
- •Life expectancy more than 3 months
- •Performance status inferior to 3
- •signed inform consent
排除标准
- •allergy to quinolone
- •previous event of tendopathy due to quinolone
- •previous epileptic event
- •systemic antibacterial prophylaxis the month before enrolment
- •HIV positive
- •bacterious infection of indetermined fever
- •participation to an investigational drug trial
- •Abnormalities in hepatic assessment
- •QTc superior to 450 ms
- •Pregnant or lactating women
- •Myasthenia
- •G6PD deficient
- •severe and uncontrolled diabetes
- •patient not able to understand trial
研究组 & 干预措施
antibacterial prophylaxis
Levofloxacin 500 mg/d p.o. during the first 3 cycles of azacytidine
干预措施: Levofloxacin (Drug)
结局指标
主要结局
Febrile episode occurrence
时间窗: 3 cycles of 28 days
Febrile episode occurrence during the3 first cycles of azacytidine requiring hospitalization and introduction of an antibiotic (with or without levofloxacin discontinuation
次要结局
- carbapenem and glycopeptide consumption in both two arms(3 years)
- death causes(one year)
- toxicity profile (adverse event)(one year)
- one-year overall survival rate(one year)
- infectious agents documented in each arm(one year)
- infectious events rate(one year)
- apparition of multi-drug resistant bacteria(one year)
- duration of hospitalization(one year)