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临床试验/ISRCTN86140460
ISRCTN86140460已完成未知

A comparison of doxycycline plus trimethoprim-sulphamethoxazole versus trimethoprim-sulphamethoxazole as maintenance therapy for melioidosis

Khon Kaen University (Thailand)0 个研究点目标入组 600 人开始时间: 2005年11月23日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
600

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

性别
All

入选标准

  • 1. Culture-confirmed melioidosis
  • 2. Satisfactory completion of intravenous therapy and able to take oral medication
  • 3. Patients with mild localised disease who are not considered to require intravenous treatment by their primary physician are eligible if they agree to return for follow up
  • 5. Aged over 14 years, either sex
  • 6. High likelihood of completing at least six months follow up
  • 7. Willingness to participate in the study and written, informed consent obtained from the patient

排除标准

  • 1. Pregnancy or breast feeding
  • 2. Contraindications to doxycycline: severe hepatic impairment (aspartate aminotransferase [AST], alanine aminotransferase [ALT] more than or equal to five times of upper limit of normal)
  • 3. Contraindications to TMP-SMX: Glucose-6-phosphate dehydrogenase (G6PD) deficiency, renal impairment (creatinine clearance less than 15 ml/min)
  • 4. History of hypersensitivity to doxycycline, TMP or SMX
  • 5. Infecting isolate is resistant to TMP-SMX by E-test
  • 6. Relapse melioidosis with disease free interval of less than two years

研究者

发起方
Khon Kaen University (Thailand)

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