Five-day Concomitant Versus 10-day Sequential Therapy for Eradication of Helicobacter Pylori Infection: a Randomized Trial of Levofloxacin-based Regimens
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Eradication Rate
研究概览
简要总结
A five day quadruple concomitant therapy is as effective and safe as a 10 day sequential therapy for eradication of H. pylori infection.
详细描述
The investigators studied 180 consecutive patients with H. pylori infection who were randomized to 5-day concomitant therapy (90 patients) and to 10-day sequential therapy (90 patients). 6 and 10 weeks after the end of therapy, patients were evaluated for their H. pylori status by 13C Urea Breath Test. Side effects and costs of either regimen were evaluated. In patients whose H pylori status at entry was assessed by endoscopy, culture was performed and antimicrobial resistance was determined
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •H. pylori-infected patients who were at least 18 years of age and who had never received H. pylori eradication treatment were included in the study.
排除标准
- •previous treatment for H. pylori infection,
- •use of inhibitors of acid secretion and/or antibiotics during the 6 weeks before the study,
- •gastrointestinal malignancy,
- •previous gastro-oesophageal surgery,
- •severe concomitant cardiovascular,
- •respiratory or endocrine diseases,
- •clinically significant renal or hepatic disease,
- •hematologic disorders,
- •any other clinically significant medical condition that could increase risk,
- •history of allergy to any of the drug used in the study,
- •pregnancy or lactation,
- •alcohol abuse,
- •drug addiction,
- •severe neurologic or psychiatric disorders, and
- •long-term use of corticosteroids or anti-inflammatory drugs.
研究组 & 干预措施
5d-QCT
5-day eradication regimen consisting in the concomitant administration of esomeprazole 40mg bid + amoxicillin 1g bid + levofloxacin 500mg bid + tinidazole 500mg bid
干预措施: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin) (Drug)
10-day sequential regimen
5 days of esomeprazole 40mg bid + amoxicillin 40mg bid followed by 5 more days of esomeprazole 40mg bid + levofloxacin 500mg bid + tinidazole 500 mg bid
干预措施: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin) (Drug)
结局指标
主要结局
Eradication Rate
时间窗: 1 year
The eradication rate obtained with the two treatments will be evaluated in the per-protocol and intention-to-treat analyses
次要结局
- Adverse events(1 year)
- Costs of either regimen(1 year)
研究者
Marco Romano
Associate Professor of Gastroenterology
University of Campania "Luigi Vanvitelli"