High Eradication Rate of Helicobacter Pylori Infection With Moxifloxacin-Based Triple Therapy in Comparison With Levofloxacin-Based Sequential Therapy: Randomized Controlled Trials
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Helicobacter pylori status one month after treatment.
研究概览
简要总结
The main objective of the study is to compare the effectiveness of moxifloxacin triple therapy with levofloxacin-based sequential therapy in terms of eradication rate, safety, and patient compliance.
详细描述
Patients who were confirmed to be positive for Helicobacter Pylori infection were randomly assigned to the eradication treatments. At four weeks after completion of eradication therapy, H. pylori tests were performed with a Stool antigen test.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Successful isolation of H. pylori from the patient, and
- •patients of at least 18 years of age.
排除标准
- •age under 18 years
- •presence of clinically significant associated conditions (insulin-dependent diabetes mellitus, gastrointestinal bleeding, neoplastic diseases, coagulation disorders, and neurologic, metabolic, hematological or endocrine hepatic, cardiorespiratory, or renal diseases),
- •previous gastric surgery,
- •allergy to any of the drugs used in the study, and (5) pregnancy or breastfeeding.
研究组 & 干预措施
Levofloxacin-based sequential Therapy
-
Tablets Levofloxacin 500mg BID for the first five days
-
Tablet Amoxicillin 1 gm BID for first five days
-
Capsules Omeprazole 20 mg BID for first five days followed by
-
Tablet Levofloxacin 500 mg BID for five days 2. Tablet Tinidazole 500mg BID for five days 3. Capsule Omeprazole 20 mg BID for five days
Infection eradication will be observed and confirmed by stool antigen test correlated with the signs and symptoms
干预措施: Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID (Drug)
Moxifloxacin-based Triple Therapy
- Tablet Moxifloxacin 400 mg OD for ten days
- Tablet Amoxicillin 1 gm BID for ten days
- Capsule Omeprazole 20 mg BID for ten days
Infection eradication will be observed and confirmed with a stool antigen test along with patient compliance and tolerability observance.
干预措施: Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID (Drug)
结局指标
主要结局
Helicobacter pylori status one month after treatment.
时间窗: One month after finishing with therapy.
Helicobacter pylori status (positive or negative), will be measured by stool test, one month after finishing with therapy.
次要结局
- Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection.(One month after finishing with therapy.)
- Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection.(One month after finishing with therapy.)
研究者
Iyad Naeem Muhammad, PhD
Associate Professor
University of Karachi