Vonoprazan-based Therapy Versus Standard Regimen for Helicobacter Pylori Infection Management
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Determination of the eradication rates for each regimen
研究概览
简要总结
Appropriately, half of the global population is infected with H. pylori, and it is now recognized that it causes at least 95% of all gastric cancers. Currently, the main challenge in the field of H. pylori infection is the rapidly increasing antibiotic resistance worldwide, which is causing a decline in the effectiveness of currently available eradication regimens.
The aim of the study is to assess the safety and efficacy of different H. pylori vonoprazan-based regimens compared to the commonly used standard triple therapy composed of Clarithromycin, Amoxicillin, and Proton pump inhibitor to eradicate H. pylori infection in treatment-naive patients through the determination of each regimen eradication rate and reported safety profile
详细描述
- Ethical committee approval is obtained from Ethics committee of Faculty of Medicine, Alexandria University.
- All participants should agree to take part in this clinical study and will provide informed consent.
- Patients with suspected H. pylori infection are recruited from Alexandria University out-patient clinics
- Participants' demographic data, Full medical and medication history, and detailed clinical presentation is documented
- Participants are tested for H. pylori infection using rapid H. pylori stool antigen test device
- Negative subjects are excluded while positive patients are randomly allocated to 3 groups of different H. pylori regimens (Standard triple, Vonoprazan dual, and Vonoprazan triple)
- Following up treatment side effects while taking the medications.
- Assessing regimens effectiveness through patient retesting at least 1 month after treatment completion.
- Assessing patient compliance to different regimens during the final visit.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Results, conclusion, discussion and recommendations will be given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with positive stool antigen test result for H. pylori
- •Patients recently diagnosed with H. pylori infection and did not receive any treatment
排除标准
- •Patients sensitive to any of the regimens' components
- •Patients who had received a previous eradication therapy and still show positive test results
- •Recent use of antimicrobial agents, proton pump inhibitors, and H2 receptor blockers within 1 month
- •Patients with gastric malignancy or who underwent previous gastric surgery
- •Pregnancy and lactation
- •Patients with major concomitant diseases, including psychic disorders
研究组 & 干预措施
S3
Standard clarithromycin triple
干预措施: standard Clarithromycin triple therapy (Drug)
V3
Vonoprazan triple
干预措施: Vonoprazan triple therapy (Drug)
V2
Vonoprazan dual
干预措施: Vonoprazan dual therapy (Drug)
结局指标
主要结局
Determination of the eradication rates for each regimen
时间窗: 1.5 month
Percentage eradication in each group is calculated by intention-to-treat analysis or per-protocol analysis.
次要结局
- Determination of number of compliant participants to each regimen(1.5 month)
- Determination of number of participants with treatment related adverse events(2 weeks)
研究者
Yumna Mohamed Shekeban
Teaching Assistant at clinical pharmacy and pharmacy practice department, faculty of pharmacy Alexandria University
Alexandria University