Comparison of Conventional Clarithromycin Vs Alternative Levofloxacin Based Regimen in Treatment of Helicobacter Pylori Infection
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 主要终点
- Treatment of H pylori infection
研究概览
简要总结
The goal of this interventional study is to compare the efficacy of clarithromycin Vs levofloxacin based regimen in treatment of Helicobacter pylori infection in patients presenting to medical OPD who are tested positive for H pylori infection.. The main question[s] it aims to answer are:
• Which regimen is superior in terms of efficacy Participants will be treated for H pylori Infection in with two different regimen If there is a comparison group: Researchers will compare two groups Group 1 will receive clarithromycin based regimen group 2 will receive levofloxacin based regimen to see the treatment response.
详细描述
This interventional study will be conducted in department of medicine, Rehman Medical Institute, Peshawar.
Study duration: 10 months after the issuance of ethical approval Sample size: Sample size is calculated using a two-tailed alpha test with a significance level of 0.05 and 90% power to detect 23% difference in the eradication rate of the two regimens. The total number of patients required to prove the hypothesis is 156, 78 in each group.
Study population: Patients coming to OPD with symptoms suggestive of H pylori infection will undergo screening by Hpylori stool antigen. If it comes to be positive then they will be enrolled in study after applying inclusion/exclusion criteria.
Inclusion criteria: All patients who tested positive on stool antigen will be included. Age >12 years and both genders will be included.
Exclusion criteria: patients under 12 years old. Patients who have penicillin allergy.
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
- 12 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who tested positive on stool antigen will be included.
排除标准
- •patients under 12 years old. Patients who have penicillin allergy.
- •Patients who have underlying dysrhythmia forbidding the use of macrolide.
- •Patient who have hypersensitivity to any of these antibiotics.
研究组 & 干预措施
Regime 1
This arm will receive clarithromycin based regimen for eradication of H pylori infection (as per approved guidelines)
干预措施: Clarithromycin (Drug)
Regime 2
This arm will receive levofloxacin based regimen for eradication of H pylori infection (as per approved guidelines)
干预措施: Levofloxacin (Drug)
结局指标
主要结局
Treatment of H pylori infection
时间窗: 2weeks after completion of treatment regimen
Treatment of H pylori infection documented by negative stool antigen
次要结局
未报告次要终点
研究者
Wajeeha Qayyum
Consultant/Assistant Professor Medicine
Rehman Medical Institute - RMI