临床试验/NCT04901117

NCT04901117Unknown4 期

Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Multicenter Randomized Clinical Trial of 10 and 14 Days

Shandong University1 个研究点分布在 1 个国家目标入组 1,300 人开始时间: 2021年6月最近更新: 2021年5月25日

适应症

干预措施

试验速览

阶段: 4 期
发起方
入组人数: 1,300
试验地点: 1
主要终点: Eradication rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.

详细描述

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent form, the researchers randomized the subjects in groups: subjects received a 10-day or 14-day course of bismuth-containing quadruple eradication therapy. The medication of groups are as follows. 6-8 weeks after the eradication treatment, the subjects will review the 13C-urea breath test, and the researcher records the results.

After all subjects were tested, the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group were calculated.

According to the course of treatment, it is randomized into a 10-day treatment group and a 14-day treatment group. The two groups of bismuth quadruple regimens are the same, as follows:

Option 1: Amoxicillin + Clarithromycin + Bismuth + Vonoprazan fumarate Option 2: Amoxicillin + Tetracycline + Bismuth + Vonoprazan fumarate Option 3: Amoxicillin + Metronidazole + Bismuth + Vonoprazan fumarate Three options are selected according to the hospital's situation.

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

•Patients aged 18-
•Patients with H.pylori infection (Positive for any of the following: H.pylori culture, histopathology test, rapid urease test, 13C/14C-urea breath test, stool H.pylori antigen test).
•Patients whose birth place and residence within five years of birth are Shandong Province.
•Patients who have never received H. pylori eradication treatment.

排除标准

•Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 3 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.
•Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
•Patients with active gastrointestinal bleeding.
•Patients with a history of upper gastrointestinal surgery.
•Patients allergic to treatment drugs.
•Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks
•Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
•Patients whose current residence is not in Shandong Province.
•Patients whose re-check 13C/14C-urea breath test is negative before the start of the test.
•Patients who are unwilling or incapable to provide informed consents.

研究组 & 干预措施

10-day treatment group

Experimental

Use the following drug combination option for 10 days. Option 1: Amoxicillin + Clarithromycin + Bismuth + Vonoprazan fumarate Option 2: Amoxicillin + Tetracycline + Bismuth + Vonoprazan fumarate Option 3: Amoxicillin + Metronidazole + Bismuth + Vonoprazan fumarate Three options are selected according to the hospital's situation.

The dosage of each drug is:

Amoxicillin (Amoxicillin, United Laboratories Co., Ltd.) 1000mg bid Clarithromycin (Klacid, Abbott S.r.l) 500mg bid Tetracycline 500mg qid Metronidazole400mg qid Bismuth Potassium Citrate (Livzon Pharmaceutical Group Inc.) 220mg bid Colloidal Bismuth Pectin (North China Pharmaceutical Co., Ltd.) 200mg bid Vonoprazan fumarate (VOCINTI, Takeda Pharmaceutical Company Limited, Hikari Plant) 20mg bid

干预措施: Amoxicillin (Drug)

10-day treatment group

Experimental

The dosage of each drug is:

干预措施: Clarithromycin (Drug)

10-day treatment group

Experimental

The dosage of each drug is:

干预措施: Tetracycline (Drug)

10-day treatment group

Experimental

The dosage of each drug is:

干预措施: Metronidazole (Drug)

10-day treatment group

Experimental

The dosage of each drug is:

干预措施: Bismuth Potassium Citrate (Drug)

10-day treatment group

Experimental

The dosage of each drug is:

干预措施: Colloidal Bismuth Pectin (Drug)

10-day treatment group

Experimental

The dosage of each drug is:

干预措施: Vonoprazan fumarate (Drug)

14-day treatment group

Active Comparator

Use the following drug combination option for 14 days. Option 1: Amoxicillin + Clarithromycin + Bismuth + Vonoprazan fumarate Option 2: Amoxicillin + Tetracycline + Bismuth + Vonoprazan fumarate Option 3: Amoxicillin + Metronidazole + Bismuth + Vonoprazan fumarate Three options are selected according to the hospital's situation.

The dosage of each drug is:

干预措施: Amoxicillin (Drug)

14-day treatment group

Active Comparator

The dosage of each drug is:

干预措施: Tetracycline (Drug)

14-day treatment group

Active Comparator

The dosage of each drug is:

干预措施: Clarithromycin (Drug)

14-day treatment group

Active Comparator

The dosage of each drug is:

干预措施: Metronidazole (Drug)

14-day treatment group

Active Comparator

The dosage of each drug is:

干预措施: Bismuth Potassium Citrate (Drug)

14-day treatment group

Active Comparator

The dosage of each drug is:

干预措施: Colloidal Bismuth Pectin (Drug)

14-day treatment group

Active Comparator

The dosage of each drug is:

干预措施: Vonoprazan fumarate (Drug)

结局指标

主要结局

Eradication rate

时间窗: Immediately after follow-up check.

Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.

次要结局

Rate of adverse reactions(Immediately after follow-up check.)
Patient compliance(Immediately after follow-up check.)
Cost-effectiveness index(Immediately after follow-up check.)

研究者

发起方

Shandong University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Xiuli Zuo

Director of Qilu Hospital gastroenterology department

Shandong University

研究点 (1)

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