Antibacterial Prophylaxis With Imipenem vs no Prophylaxis for Hematological Malignancies Patients Before Allogenetic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Infectious incidence
研究概览
简要总结
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative treatment for a variety of hematologic malignancies. Bacterial infections remain a common complication of allo-HSCT, especially in the pre-engraftment phase. Pre-engraftment neutropenia typically lasts for up to 2 weeks in autologous HSCT but is considerably longer in allogeneic HSCT recipients who receive myeloablative conditioning regimens. This is a prospective, randomized, controlled, phase II/III clinical trial that aims to investigate the beneficial and harmful effects of prophylactic use of imipenem in patients with hematological malignancies before allo-HSCT. All patients aged above 14 years, diagnosed with hematological malignancies and ready to undergo allo-HSCT, no active infection within 3 weeks before allo-HSCT, with a normal CT scan-chest before entering the transplantation cabin and willing to participate in the trial will be enrolled.
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
- 14 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged above 14 years;
- •diagnosis with hematological malignancies and be ready to undergo allo-HSCT;
- •no active infection within 3 weeks before allo-HSCT;
- •with a normal CT scan-chest before entering the transplantation cabin.
排除标准
- •age < 14 years;
- •active and documented infection at admission;
- •with a abnormal CT scan-chest before entering the transplantation cabin;
- •with any conditions not suitable for the trial;
- •unwilling to participate in the trial.
研究组 & 干预措施
Imipenem prophylaxis group
Imipenem: 1g q8h i.v. daily for 5 consecutive days before the onset of conditioning of allo-HSCT
干预措施: Imipenem (Drug)
结局指标
主要结局
Infectious incidence
时间窗: pre-engraftment in allo-HSCT
次要结局
- Overall survival (OS)(2 years)
- Incidence of acute GVHD(100 days)
研究者
Qifa Liu
Prof.
Nanfang Hospital, Southern Medical University
