NCT06065267尚未招募4 期
Efficacy of Two-week Therapy With Levofloxacin-based Concomitant Regimen Versus Levofloxacin-based Sequential Regimen for Helicobacter Pylori Infection in Syrian Population: a Prospective Single-center Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Eradication rate of Helicobacter pylori infection
研究概览
简要总结
The goal of this trial is to determine the efficacy of levofloxacin based sequential treatment regimen or concomitant levofloxacin based regimens as empirical first-line therapy in the 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
- Double (Investigator, Outcomes Assessor)
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
- 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:
- •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
concomitant
Active Comparator
Measure eradication rate of Helicobacter pylori infection with Livofloxacine concomitant based regimen
干预措施: Levofloxacin 500Mg Oral Tablet (Drug)
sequential
Experimental
Measure eradication rate of Helicobacter pylori infection with Levofloxacien sequential based regimen
干预措施: sequential (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
Marouf Alhalabi
head of digestive diseases department
Damascus Hospital
研究点 (1)
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