Randomized, Controlled, Multicenter Phase III Study for the Efficacy and Tolerability of Triple Therapy With Esomeprazole, Moxifloxacin and Amoxicillin for Rescue Therapy of Helicobacter Pylori Infection
试验速览
- 阶段
- 3 期
- 入组人数
- 132
- 试验地点
- 10
- 主要终点
- Efficacy of a combination of esomeprazole (E), moxifloxacin (M) and amoxicillin (A) for third line therapy of H. pylori infection.
研究概览
简要总结
Successful H. pylori eradication therapy remains a challenge in medical practice. Despite promising data for first-line, second-line and rescue treatment options based on clinical trials as well as guidelines and expert recommendations, success rates can often not be reproduced in general practice. Rescue options for patients with failed initial or second-line therapy are definitely needed. The new fluoroquinolone moxifloxacin may represent an effective and save treatment option (in combination with a PPI and amoxicillin) for rescue therapy of H- pylori positive patients.However, optimal duration of therapy (7-day course vs 14-day course) has to be determined
详细描述
Successful H. pylori eradication therapy remains a challenge in medical practice. Currently, a PPI - based triple therapy containing clarithromycin, amoxicillin or nitroimidazole given for 7 days is the recommended first line treatment approach with an expected eradication success rate of approximately 80%. As second-line treatment option in case of failure, a RBC-based quadruple therapy is currently recommended curing another 80% of patients, leaving a subset of patients with persistent H. pylori infection. Resistance to fluoroquinolones is low in most countries,hence these compounds are potential candidates for second-line and rescue treatment. The new fluoroquinolone moxifloxacin launched by Bayer in 1999 for the treatment of respiratory tract infections, has a broad antibacterial spectrum comparable to levofloxacin but fewer phototoxic and central nervous system excitatory effects. The possible role of moxifloxacin in H. pylori eradication is since under clinical investigation
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
- •male/female, age >/=18 years
- •Helicobacter pylori infection proven by histology and culture
- •indication for eradication therapy according to the Maastricht-III
- •at least one failed prior eradication attempt
- •pretherapeutic resistance testing (culture)
- •written informed consent
排除标准
- •in vitro resistance to moxifloxacin or amoxicillin
- •current complicated peptic ulcer disease
- •daily intake of NSAIDs
- •co-medication with drugs known to interact with the study medication
- •history of gastric surgery/vagotomy
- •medical treatment for depression, known suicide attempt
- •severe cardiological diseases such as bradyarrythmia, QT changes
- •malignant disease
- •gravidity, nursing
- •women with child bearing potential must perform contraceptive measures
结局指标
主要结局
Efficacy of a combination of esomeprazole (E), moxifloxacin (M) and amoxicillin (A) for third line therapy of H. pylori infection.
Comparison of EMA 7 days versus EMA 14 days. Hypothesis: superiority of EMA 14 days 4 weeks after end of eradication therapy
次要结局
- Tolerability,safety, post treatment resistance, influence of host genetics (CYP status) and pathogenicity factors of H. pylori on treatment success.