跳至主要内容
临床试验/PACTR202402557039838
PACTR202402557039838招募中2 期

Safety and tolerability of adjunct dexamethasone in addition to standard of care antiviral therapy compared to standard of care antiviral therapy alone for the treatment of moderate to severe Lassa Fever: An open label randomized controlled phase II clinical trial

Bernhard Nocht Institute for Tropical Medicine0 个研究点目标入组 42 人开始时间: 2024年1月16日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
42

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
19 Year(s) 至 44 Year(s)(—)
性别
All

入选标准

  • Age = 18 years
  • -LF confirmed by RT-PCR with a Ct value < 30
  • -Signs of significant health impairment as evidenced by any of the following:
  • oACVPU other than A
  • oSystolic blood pressure < 90 mmHg
  • oSeizure(s), meningism, coma, focal neurological deficit
  • oAST (GOT) >3xULN
  • oALT (GPT) > 3xULN
  • oKDIGO 2 or more severe based on serum creatinine only (where preceding value of creatinine is not available, the upper limit of the normal range should be used as reference)
  • oActive macroscopic bleeding
  • oO2 saturation < 92

排除标准

  • -Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)
  • -Lactation following live birth
  • -Known intolerance and contra-indications to ribavirin or dexamethasone
  • -Patients who already received a corticosteroid within the preceding 7 days
  • -Investigator’s valuation that patient might be put to substantial risk by participating in this trial
  • -Patients receiving end-of-life care as judged by the investigator

研究者

发起方
Bernhard Nocht Institute for Tropical Medicine

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