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临床试验/NCT03733340
NCT03733340Unknown2 期

Antibacterial Prophylaxis With Imipenem vs no Prophylaxis for Hematological Malignancies Patients Before Allogenetic Hematopoietic Stem Cell Transplantation

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2018年12月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Qifa Liu

Prof.

Nanfang Hospital, Southern Medical University

研究点 (1)

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