Comparison of Daily Single Dose Triple and Conventional Triple Therapies for Helicobacter Pylori Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- The rate of H.pylori eradication
研究概览
简要总结
This study is conducted to investigate whether the efficacy of single-dose triple therapy (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the treatment of H pylori infection.
详细描述
Multiple regimens have been evaluated for H. pylori therapy in randomized controlled trials The treatment regimen that is selected must be effective, but considerations such as cost, side effects, and ease of administration should also be taken into account. Despite the number of studies, the optimal therapeutic regimen has not yet been defined.
The regimen most commonly recommended for first line treatment of H. pylori is triple therapy with a PPI, amoxicillin and clarithromycin for 14 days. However, the multi-drug application is associated with remarkable side effects and it is not uncommon not to be able to complete a treatment course. Thus, treatment failure is associated with H. pylori strains that are resistant to the commonly used antibiotics. This study is conducted to investigate whether the efficacy of single-dose triple therapy (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the treatment of H pylori infection.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients who proved H. pylori infection following three methods
- •Positive rapid urease test
- •Histologic evidence of H. pylori by modified Giemsa staining
- •Positive stool Antigen Test
排除标准
- •Patients who received eradication therapy for H. pylori infection, previously
- •H. pylori eradication failure because of poor compliance
- •The administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks
- •Advanced gastric cancer or other malignancy
- •Abnormal liver function or liver cirrhosis
- •Abnormal renal function or chronic kidney disease
- •Other severe concurrent diseases
- •Previous allergic reactions to the study drugs
- •Pregnant or lactating women
研究组 & 干预措施
Tavanex & Nexium & Tinafas
Patients will receive Nexium (Esomeprazole) 40 mg daily and Tinafas (Tinidazole) 1 g daily and Tavanex (Levofloxacin) 500 mg daily for 14 days"
干预措施: Nexium (Drug)
Tavanex & Nexium & Tinafas
Patients will receive Nexium (Esomeprazole) 40 mg daily and Tinafas (Tinidazole) 1 g daily and Tavanex (Levofloxacin) 500 mg daily for 14 days"
干预措施: Tinafas (Drug)
Tavanex & Nexium & Tinafas
Patients will receive Nexium (Esomeprazole) 40 mg daily and Tinafas (Tinidazole) 1 g daily and Tavanex (Levofloxacin) 500 mg daily for 14 days"
干预措施: Tavanex (Drug)
Lanzol & Klacid &Iramox
Patients will receive Lanzol (lansoprazole) 30 mg twice daily and Klacid (clarithromycin) 500 mg twice daily and Iramox (amoxicillin) 1 g twice daily for 14 days
干预措施: Lanzol (Drug)
Lanzol & Klacid &Iramox
Patients will receive Lanzol (lansoprazole) 30 mg twice daily and Klacid (clarithromycin) 500 mg twice daily and Iramox (amoxicillin) 1 g twice daily for 14 days
干预措施: Klacid (Drug)
Lanzol & Klacid &Iramox
Patients will receive Lanzol (lansoprazole) 30 mg twice daily and Klacid (clarithromycin) 500 mg twice daily and Iramox (amoxicillin) 1 g twice daily for 14 days
干预措施: Iramox (Drug)
结局指标
主要结局
The rate of H.pylori eradication
时间窗: 42 days after study completion
Breath Urea Test
次要结局
- Drug Compliance(within the first week after study completion)
研究者
Zahra Vahdat Shariatpanahi
Assistant Professor
Ilam University of Medical Sciences