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临床试验/IRCT20140818018842N37
IRCT20140818018842N37招募中2 期

Comparison of high dose versus low dose of fluconazole for primary prevention of candida infections in patients with hematological malignancies, A single blind prospective randomized clinical trial

Research Institute for Oncology, Hematology and Cell Therapy0 个研究点目标入组 120 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
120

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

年龄范围
18 years 至 no limit(—)
性别
All

入选标准

  • Age above 18 years
  • All patients with hematological malignancies can receive a prophylactic regimen against Candida, including: Patients with acute leukemia undergoing primary induction or salvage chemotherapy with the possibility of developing Mucositis
  • Patients with acute leukemia or Myelodysplastic syndromes (MDS) who are expected to experience severe and fatal neutropenia (ANC<500 for more than 7 days) following chemotherapy
  • Having the informed consent of the patient to participate in the study

排除标准

  • Patients with history of idiosyncratic hypersensitivity reaction to azoles
  • Patients with disturbed liver tests with transaminases more than 10 times the normal limit
  • Life expectancy less than 3 weeks
  • History of treatment with systemic antifungal drugs in the last two weeks
  • Patients who have been diagnosed with a fungal infection and are suffering from a fungal infection
  • Patients with increased QTc interval or Torsades de pointes
  • Patients receiving drugs with major clinical interaction (category X) with fluconazole
  • Having a history of invasive fungal infection requiring systemic treatment in the last 6 months
  • Failure to receive fluconazole for more than 3 days during the study
  • Patients with renal failure as CrCl =50 mL/min
  • breastfeeding

研究者

发起方
Research Institute for Oncology, Hematology and Cell Therapy

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