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临床试验/NCT04626193
NCT04626193Unknown4 期

Comparing the Efficacy of Two Weeks Therapy of Doxycycline,Levofloxacin,Tinidazole Versus Levofloxacin With Tinidazole on Rate of Eradication of Helicobacter Pylori Infected Patients on Syrian Population

Damascus Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年10月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
80
试验地点
1
主要终点
Eradication rate of Helicobacter pylori infection

研究概览

简要总结

Comparison Efficacy of two weeks Therapy with Doxycycline,levofloxacine,Tinadizole Versus Levofloxacine,Tinadizole,Amocillin on Eradication of Helicobacter Pylori in Syrian population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods:
  • Positive rapid urease test (CLOtest).
  • Histologic evidence of H. pylori by modified Giemsa staining.
  • Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy.

排除标准

  • Children and teenagers aged less than 18 years.
  • Previous eradication treatment for H. pylori.
  • Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.
  • History of gastrectomy.
  • Gastric malignancy, including adenocarcinoma and lymphoma,
  • Previous allergic reaction to antibiotics (Amoxicillin, Tinadizole,
  • Doxycycline,Bismuth subsalicylate,) and prompt pump inhibitors (Es- omeprazole).
  • Contraindication to treatment drugs.
  • Pregnant or lactating women.
  • Severe concurrent disease.
  • Liver cirrhosis.

研究组 & 干预措施

Doxycyclien

Experimental

Measure eradication rate of Helicobacter pylori infection with Doxycycline,Levofloxacien,tinadizole

干预措施: Doxycycline (Drug)

Levofloxacine

Active Comparator

Measure eradication rate of Helicobacter pylori infection with Livofloxacine and tinadizole,amoxicilline

干预措施: Levofloxacin 500mg (Drug)

结局指标

主要结局

Eradication rate of Helicobacter pylori infection

时间窗: 8 week from begning of treatment

Eradication rate of Helicobacter infected patients

次要结局

未报告次要终点

研究者

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

Marouf Alhalabi

head of digestive diseases department

Damascus Hospital

研究点 (1)

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