Antimicrobial Susceptibility for Helicobacter Pylori Eradication
关键词
抽象
描述
Usefulness of antimicrobial susceptibility in the eradication of Helicobacter pylori
PURPOSE
Background:
- The rate of eradication of Helicobacter pylori with standard triple therapy (OCA: omeprazole + clarithromycin + amoxicillin) in our area is less than the expected according to the III Maastricht III consensus. However, the current guidelines recommend the use of this therapy.
- According to the Maastricht III consensus, in populations with high rates of clarithromycin resistance (15-20%) another therapy should be considered, or alternatively, testing antimicrobial susceptibility of the H. pylori prior to treatment.
Objectives:
- To clarify the real rate of eradication with OCA therapy with and without antimicrobial susceptibility in our area (with high rate of resistance to clarythromycin).
- To study which is the diagnostic-therapeutic strategy more cost-effective for the treatment of H. pylori.
Design:
- Participants will be screened with a full medical history.
- Participants will aleatory receive OCA therapy empirically, or after antimicrobial susceptibility test if there is no resistance to clarythromycin, for ten days.
- In all cases the eradication of H. pylori will be checked by 13C urea breath test (UBT) in 8 weeks after the therapy have been finished.
- All the adverse event of the therapy will be reported.
日期
| 最后验证: | 11/30/2011 |
| 首次提交: | 11/18/2011 |
| 提交的预估入学人数: | 12/01/2011 |
| 首次发布: | 12/05/2011 |
| 上次提交的更新: | 12/10/2011 |
| 最近更新发布: | 12/12/2011 |
| 实际学习开始日期: | 01/31/2011 |
| 预计主要完成日期: | 10/31/2011 |
| 预计完成日期: | 04/30/2012 |
状况或疾病
干预/治疗
Other: OCA 10
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Empirical OCA This group will be treated with omeprazole, amoxicillin and clarithromycin without having a previous antibiogram. | |
| OCA after antibiogram This group will be treated with omeprazole, clarithromycin and amoxicillin after an antibiotic susceptibility confirmation. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 取样方式 | Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Diagnosis of H. pylori infection provided by culture, histology or UBT. - Patients need and indication to treat (peptic ulcer disease, firs-degree family history of gastric cancer, MALT lymphoma or dyspeptic symptoms) - Patients must be 18 years or older. Exclusion criteria: - Previous treatment for H. pylori eradication. - Patients who have severe concomitant disease. - Patients who have previous gastric surgery. - Patients who have intolerance to any antimicrobial drugs. |
结果
主要结果指标
1. Number of patients in whom Helicobacter pylori was eradicated. [9 months]
次要成果指标
1. Number of patient with adverse event [9 months]
2. Cost of the eradication of Helicobacter Pylori in each group. [9 months]
