Efficacy and Safety of 14-day Concomitant Therapy for Helicobacter Pylori: A Pilot Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Eradication rates
研究概览
简要总结
The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the third-line treatment of Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates.
详细描述
Helicobacter pylori infects half of the world's population. H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly increasing antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted. Few published paper evaluated the efficacy of 14-day furazolidone containing concomitant therapy in the third line treatment. This study aims to propose a new concomitant therapy for the patients with two or more treatment failure, and then evaluates whether adverse effects are tolerable. .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-70 with persistent H. pylori infection.
- •Patients failed at least three different standard eradication therapies before. Previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to Maastricht V report.
排除标准
- •Patients unable or unwilling to receive gastroscopy.
- •Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.
- •Patients with gastorectomy, acute GI bleeding and advanced gastric cancer.
- •History of allergy to any of the drugs used in the study.
- •Severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk.
- •Currently pregnant or lactating.
- •Severe neurologic or psychiatric disorders.
- •Alcohol abuse or drug addiction.
- •Patients with compliance lower than 90% in any previous treatment are not included.
- •Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
研究组 & 干预措施
14d concomitant therapy
Patients will receive a 14-day concomitant therapy containing esomeprazole, amoxicillin, tetracycline and furazolidone.
干预措施: esomeprazole, amoxicillin, furazolidone，tetracycline (Drug)
结局指标
主要结局
Eradication rates
时间窗: 6 months
Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infection. The ITT analysis includes all the patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
次要结局
- The rate of adverse events happening(6 months)
- The rate of good compliance(6 months)
- Changes of dyspepsia symptoms after Helicobacter pylori eradication(6 months)
研究者
Xiuli Zuo
director of Qilu Hospital gastroenterology department
Shandong University