Efficacy of Amoxicillin-Esomeprazole High Dose Dual Therapy Compared to Levofloxacin Containing Triple Therapy for the Eradication of Helicobacter Pylori in a Tertiary Care Hospital: A Single-blind Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- To compare the efficacy of amoxicillin-esomeprazole HDDT therapy with levofloxacin triple therapy for the eradication of Helicobacter pylori
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of two different therapeutic regimen for the treatment of Helicobacter pylori infected dyspeptic patients. The aim is -
- To identify the percentage of H. pylori infection among dyspeptic patients
- To compare the efficacy of amoxicillin-esomeprazole high dose dual therapy with levofloxacin containing triple therapy for the eradication of Helicobacter pylori.
Participants will be screened on the basis of two different test (stool antigen test & endoscopy with rapid urease test) to detect H. pylori infection. Who are positive on both tests will be finally enrolled in the study and randomized into two groups . one group will receive amoxicillin & esomeprazole for 14 days in higher dose. The other group will receive amoxicillin, levofloxacin & esomeprazole for 14 days in usual dose.
Dyspeptic symptoms will be recorded before & after treatment. Side effects of drugs will also be recorded. Finally 1 month after completion of treatment , H.pylori status will be cheeked by stool antigen test and results will be compared between two groups.
详细描述
Introduction:
Helicobacter pylori infection is one of the most common infections worldwide and represents a major cause of gastritis, gastric and duodenal ulcers, mucosa-associated lymphoid tissue lymphoma. Moreover, H. pylori is recognized as a class 1 carcinogen by the International Agency for Research on cancer & WHO. It is the most important risk factor for developing gastric cancer, the timely elimination of which could lead to a 75% reduction in risk.
H. pylori infection higher in developing countries as compared to industrially developed countries and the prevalence varies between populations and between groups within the same population.According to a recent meta-analysis Bangladesh has the highest prevalence of H. pylori infection among Asian countries,86%
H. pylori antimicrobial resistance is an urgent, global issue. In addition to clarithromycin, resistance to metronidazole and fluoroquinolones has also increased worldwide . A recent study in Bangladesh showed clarithromycin, metronidazole & levofloxacin resistance at 39.3% ,94.6% and 66.1% respectively. On the contrary, amoxicillin resistance is quite low, 3.6%.
Since its discovery, various H. pylori eradication regimens have been investigated around the world with variable efficacy. Recent Maastricht's VI guideline recommends susceptibility testing before prescribing 1st line treatment if possible. Otherwise, bismuth or non-bismuth quadruple therapy followed by levofloxacin containing triple or quadruple therapy for 14 day is recommended for the treatment of H. pylori. Although these treatment regimens provide acceptable H. pylori eradication rates, dual & triple resistance to antibiotics adversely affects efficacy of these regimens. Moreover, these regimens can promote resistance, due to prolonged therapy with multiple antibiotics. A new strategy that can eradicate H. pylori as well as reduce the antibiotic exposure is required to prevent future antimicrobial resistance.
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
- Single (Participant)
盲法说明
Participants will be unaware about which group of treatment they are getting but the investigator will know about the treatment allocation.
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 ≥ 18 years
- •Dyspeptic patients with positive Rapid urease test & stool antigen test
- •patients giving written informed consent
排除标准
- •Treatment with proton pump inhibitor, H2-receptor antagonist, bismuth preparation within the last 2 weeks or antibiotics within 4 weeks prior to study.
- •Previous H. pylori eradication therapy
- •Complicated duodenal ulcer patients (active bleeding and perforation)
- •Patients with regular intake of NSAIDs or steroids.
- •Surgery that might affect gastric acid secretion (upper GI resection or vagotomy)
- •Known case of malignancy
- •Advanced Co-morbidities (e.g. CLD, CKD, cardio-respiratory failure, known thyroid disease)
- •participants who are pregnant, lactating or intend to become pregnant within the duration of the study.
结局指标
主要结局
To compare the efficacy of amoxicillin-esomeprazole HDDT therapy with levofloxacin triple therapy for the eradication of Helicobacter pylori
时间窗: 1 month after completion of eradication therapy
Group A will receive amoxicillin-esomeprazole high dose dual therapy for 14 days. Group-B patients will receive levofloxacin containing triple therapy 14 days. 1 month after completion of therapy, fresh stool sample will be collected from all patients for repeat stool antigen test \& H. pylori eradication will be recorded for each group. Eradication rate will be compared between two groups.
次要结局
- Helicobacter pylori prevalence among dyspeptic patients(stool antigen test & rapid urease test will be done 14 days after stopping PPI ,H2 receptor antagonist,bismuth preparation)
研究者
Salman Rafat
Resident
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh