NCT03021590撤回4 期
Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Helicobacter pylori Eradication rate
研究概览
简要总结
Comparison Efficacy of 14-day Concomitant therapy between levofloxacin and Clarithromycin on the 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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods: I-Positive rapid urease test (CLOtest). II-Histologic evidence of H. pylori by modified Giemsa staining. III-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, Tinidazole , Levofloxacin) and prompt pump inhibitors (Es-omeprazole).
- •Contraindication to treatment drugs.
- •Pregnant or lactating women.
- •Severe concurrent disease. Liver cirrhosis. Chronic kidney disease.
- •Patients who cannot give informed consent by himself or herself.
研究组 & 干预措施
Clarithromycin :Concomitant Therapy
Experimental
Amoxicillin 1000 mg Tablets, Clarithromycin 500 mg Tablets , Tinidazole 500 mg Tablets and Esomeprazole 20 mg Capsule each every 12 hours for 14 days all by mouth
干预措施: Clarithromycin 500Mg Oral Tablet (Drug)
Levofloxacin :Concomitant Therapy
Active Comparator
Levofloxacin 500 mg Tablets Amoxicillin 1000 mg Tablets,Tinidazole 500 mg Tablets and Esomeprazole 20 mg each every 12 hours for 14 days all by mouth
干预措施: Levofloxacin 500Mg Oral Tablet (Drug)
结局指标
主要结局
Helicobacter pylori Eradication rate
时间窗: 6 weeks after eradication therapy
Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis
次要结局
未报告次要终点
研究者
研究点 (1)
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