Rifaximin Associated With Classic Triple Therapy (Inhibitor of Proton Pump, Amoxicillin and Clarithromycin) for the Eradication of Helicobacter Pylori Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of Participants With H.Pylori Infection Eradication
研究概览
简要总结
Background: A progressive decrease in Helicobacter pylori eradication rates has been described over the years, so new combinations of antibiotics for treatment are needed.
Aim: To evaluate the efficacy and safety of the addition of rifaximin to standard triple therapy (omeprazole, amoxicillin and clarithromycin) for the eradication of H. pylori.
Methods: Independent prospective pilot clinical trial (EUDRA CT: 2013-001080-23). Forty consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and naive to eradication treatment. A full blood test was performed in the first 5 patients included to evaluate the safety of the treatment. H. pylori eradication was confirmed with urea breath test at least 4 weeks after the end of treatment. Treatment: Rifaximin 400 mg/8 h, clarithromycin 500 mg/12 h, amoxicillin 1 g/12 h, and omeprazole 20 mg/12 h for 10 days.
详细描述
- STUDY DESIGN 4.1. Endpoints Main endpoint Eradication of infection "by intention to treat". Secondary endpoints Eradication of infection "per protocol". Adherence to treatment. Medication side effects.
Clinical and demographic variables:
- Age; 2) Sex; 3) Smoking habit; 4) Comorbidity (diabetes mellitus, hypertension, ischemic heart disease, dyslipidemia, others); 5) Indication of eradication (peptic ulcer vs. functional dyspepsia or not investigated) 6) Initial diagnosis test of H. pylori infection.
4.2. Clinical trial design Phase III clinical trial, prospective, pilot, open, not controlled. The recruitment period will be five months. All the tests to confirm infection with Helicobacter pylori made within a maximum period of one year, provided the patient has not taken any antibiotics able to eradicate bacteria from conducting the test until the day of inclusion, will be given as valid, for the inclusion of the patient, Patients with proven infection and that have already prescribed standard triple therapy by routine clinical practice, will be required written informed consent to participate in the study, after which treatment with Rifaximin will be added.
- At the time of enrollment, after reviewing the inclusion and exclusion criteria and obtaining the patient's consent, a medical history and complete examination will take place including: antiulcer treatment received, history of smoking and alcohol intake, aspirin consumption and NSAID. Other concomitant medications that the patient is receiving for any other process will be also recorded.
- Between days 5-15 after taking the last dose, the procedures of the follow up visit specified in section 7.3.2 will be performed to the patients. Similarly, these procedures will be performed at the time when the patient leaves the study prematurely, if need be.
- Control breath test or histology between 4 and 8 weeks after treatment ends. Before the control test, it will be confirmed that the patient has not taken proton pump inhibitors during the 15 days before or antibiotics within 4 weeks prior to the breath test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age greater than or equal to 18 years.
- •Patients with dyspeptic symptoms, ie pain or discomfort (including abdominal bloating, early satiety and bloating) centered on the upper abdomen, persistent or recurrent, with proven H. pylori infection (through testing breath or gastric biopsy based methods, if it has been done) with a validity period of one year.
- •Having been previously prescribed by routine clinical practice the standard triple therapy as eradication treatment:
- •Proton Pump Inhibitor. Omeprazole 40 mg (or equivalent) every 12 hours. Treatment duration: 10 days.
- •Clarithromycin. Dose: 500 mg every 12 hours. Treatment duration: 10 days.
- •Amoxicillin. Dose: 1000 mg every 12 hours. Treatment duration: 10 days.
- •Not having yet begun taking the eradication therapy.
- •Written informed consent from the patient.
- •The first five patients included in the study, should had cited from the outpatient and prior to his arrival in consultation, a routine analysis in the month after the completion of the eradication therapy.
- •If the patient is a woman of childbearing age, she will be asked to commit to not get pregnant or to use an adequate contraception method.
排除标准
- •Previous eradication treatment for H. pylori (these patients are often carriers of antibiotic resistant strains and have a much lower response than those that had never received treatment).
- •Allergy to any of the antibiotic in the treatment.
- •Taking antibiotics or bismuth salts since performing the breath test.
- •Previous gastric surgery.
- •Presence of severe pulmonary, hepatic, renal, endocrine, metabolic, hematologic or tumor disease.
- •Very advanced chronic disease or other conditions that prevent attending to controls and follow ups.
- •Previous history of alcohol or drugs abuse.
- •Patients who are pregnant or lactating.
研究组 & 干预措施
Rifaximin
Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice.
干预措施: Rifaximin (Drug)
结局指标
主要结局
Percentage of Participants With H.Pylori Infection Eradication
时间窗: 1 month
Percentage of Participants with H.Pylori Infection Eradication confirmed with urea breath test at least 4 weeks after the end of treatment
次要结局
- Tolerability of Treatment(1 month)
- Compliance With Treatment of Patients That Completed the Study(1 month)