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临床试验/TCTR20200910009
TCTR20200910009招募中2 期

Efficacy of Amoxicillin/Clavulanic Acid Prophylaxis in Green Pit Viper Bites: A Multi-center, Randomized, Double-Blind, Placebo-Controlled Trial, in Urban Settings.

Faculty of Medicine Vajira Hospital, Navamindradhiraj University0 个研究点目标入组 148 人开始时间: 2020年9月10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
148

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 110 Years(—)
性别
All

入选标准

  • I1. Ages>/= 18 years old
  • I2. Patients are bitten by a green pit viper and visit one of our 5 participating sites
  • I3. Elapsed time from bite to ED visit < 6 hours
  • I4. Each participant must have one of the 3 national medical care rights for treatment at one of the 5 participating hospitals in this study
  • I4.1. Universal health-care coverage Scheme (UCS) or Social Security Scheme (SSS)
  • I4.2. Civil Servant Medical Benefit Scheme
  • I4.3. If a participant has UCS at a hospital outside Bangkok and he/she wants to get a medical care at one of the participating sites.

排除标准

  • E1. Allergic to Amoxicillin/Clavulanic Acid or Penicillin
  • E2. If the bite wounds are at high risks for infection such as wound manipulation by mouth sucking, applying herbal materials, etc.
  • E3. Immunocompromised host or taking immunosuppressive drugs
  • E4. Pregnant
  • E5. Having evidence of systemic infection and having compartment syndrome
  • E6. Hemorrhagic shock or unstable vital signs
  • E7. Taking any antibiotics within 7 days prior to the bite
  • E8. Lack of literacy in Thai language
  • E9. Unable to make own decision or unable to communicate with the research team

研究者

发起方
Faculty of Medicine Vajira Hospital&#44; Navamindradhiraj University

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