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临床试验/NCT06332599
NCT06332599已完成不适用

Minocycline-containing Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: a Real-world Evidence Study

Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 823 人开始时间: 2021年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
823
试验地点
1
主要终点
Helicobacter pylori eradication rate

研究概览

简要总结

Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. We previously showed that the efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events.This study aimed to evaluate the efficacy and tolerability of four different regimens with minocycline and metronidazole compared to classical bismuth quadruple therapy for H. pylori rescue treatment in a real-world setting.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

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

  • Confirmed H. pylori infection and with previous treatment failure

排除标准

  • subjects naive to H. pylori treatment,
  • history of gastrectomy
  • pregnant or lactating women
  • severe systemic diseases or malignancy
  • administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 12 weeks

研究组 & 干预措施

BQT

干预措施: BQT (Drug)

PBM4M4

干预措施: PBM4M4 (Drug)

PBM3M3

干预措施: PBM3M3 (Drug)

PBM2M4

干预措施: PBM2M4 (Drug)

PBM2M3

干预措施: PBM2M3 (Drug)

结局指标

主要结局

Helicobacter pylori eradication rate

时间窗: Six weeks after completion of therapy

Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).

次要结局

  • Rate of adverse effects(Within six weeks after completion of therapy)
  • Compliance rate(Within six weeks after completion of therapy)

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hong Lu, MD

Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

RenJi Hospital

研究点 (1)

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