Antibiotic Susceptibility-based Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy: a Prospective Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Helicobacter pylori eradication rate
研究概览
简要总结
Increasing drug resistance presents a significant challenge to the efficacies of common empiric eradication regimens for Helicobacter pylori treatment in the mainland of China. Tailored therapy may be the best choice to achieve good efficacy, especially in patients with penicillin allergy. Few studies had evaluated the patients with penicillin allergy.This study is designed to evaluate the efficacy and safety of antibiotic sensitivity-based tailored therapy for Helicobacter pylori treatment in the patients with penicillin allergy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with penicillin allergy who have non-ulcer functional dyspepsia or scarred peptic ulcer disease
- •Ability and willingness to participate in the study and to sign and give informed consent
- •confirmed H. pylori infection
排除标准
- •Patients without penicillin allergy
- •Less than 18 years old
- •With previous gastric surgery
- •Major systemic diseases
- •Pregnancy or lactation
- •Allergy to any of the study drugs
- •Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
研究组 & 干预措施
Tailored Therapy
Medications will be adjusted according to clarithromycin，metronidazole and levofloxacin sensitivity. All drugs will be prescribed for 14 days.(1) When three of them or clarithromycin and metronidazole are sensitive, esomeprazole 20mg bid, clarithromycin 0.5g bid and metronidazole 0.4g bid will be prescribed. (2) When two of them (levofloxacin and clarithromycin or metronidazole) are sensitive, esomeprazole 20mg bid, levofloxacin 0.5g qd plus clarithromycin 0.5g bid or metronidazole 0.4g bid will be prescribed. (3) When one of them (clarithromycin or levofloxacin) is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus clarithromycin 0.5g bid or levofloxacin 0.5g qd will be prescribed.(4) When only metronidazole or none of them is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus tetracycline 0.4g qid will be prescribed.
干预措施: Esomeprazole (Drug)
Tailored Therapy
Medications will be adjusted according to clarithromycin，metronidazole and levofloxacin sensitivity. All drugs will be prescribed for 14 days.(1) When three of them or clarithromycin and metronidazole are sensitive, esomeprazole 20mg bid, clarithromycin 0.5g bid and metronidazole 0.4g bid will be prescribed. (2) When two of them (levofloxacin and clarithromycin or metronidazole) are sensitive, esomeprazole 20mg bid, levofloxacin 0.5g qd plus clarithromycin 0.5g bid or metronidazole 0.4g bid will be prescribed. (3) When one of them (clarithromycin or levofloxacin) is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus clarithromycin 0.5g bid or levofloxacin 0.5g qd will be prescribed.(4) When only metronidazole or none of them is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus tetracycline 0.4g qid will be prescribed.
干预措施: Bismuth Potassium Citrate (Drug)
Tailored Therapy
Medications will be adjusted according to clarithromycin，metronidazole and levofloxacin sensitivity. All drugs will be prescribed for 14 days.(1) When three of them or clarithromycin and metronidazole are sensitive, esomeprazole 20mg bid, clarithromycin 0.5g bid and metronidazole 0.4g bid will be prescribed. (2) When two of them (levofloxacin and clarithromycin or metronidazole) are sensitive, esomeprazole 20mg bid, levofloxacin 0.5g qd plus clarithromycin 0.5g bid or metronidazole 0.4g bid will be prescribed. (3) When one of them (clarithromycin or levofloxacin) is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus clarithromycin 0.5g bid or levofloxacin 0.5g qd will be prescribed.(4) When only metronidazole or none of them is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus tetracycline 0.4g qid will be prescribed.
干预措施: Clarithromycin (Drug)
Tailored Therapy
Medications will be adjusted according to clarithromycin，metronidazole and levofloxacin sensitivity. All drugs will be prescribed for 14 days.(1) When three of them or clarithromycin and metronidazole are sensitive, esomeprazole 20mg bid, clarithromycin 0.5g bid and metronidazole 0.4g bid will be prescribed. (2) When two of them (levofloxacin and clarithromycin or metronidazole) are sensitive, esomeprazole 20mg bid, levofloxacin 0.5g qd plus clarithromycin 0.5g bid or metronidazole 0.4g bid will be prescribed. (3) When one of them (clarithromycin or levofloxacin) is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus clarithromycin 0.5g bid or levofloxacin 0.5g qd will be prescribed.(4) When only metronidazole or none of them is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus tetracycline 0.4g qid will be prescribed.
干预措施: Metronidazole (Drug)
Tailored Therapy
Medications will be adjusted according to clarithromycin，metronidazole and levofloxacin sensitivity. All drugs will be prescribed for 14 days.(1) When three of them or clarithromycin and metronidazole are sensitive, esomeprazole 20mg bid, clarithromycin 0.5g bid and metronidazole 0.4g bid will be prescribed. (2) When two of them (levofloxacin and clarithromycin or metronidazole) are sensitive, esomeprazole 20mg bid, levofloxacin 0.5g qd plus clarithromycin 0.5g bid or metronidazole 0.4g bid will be prescribed. (3) When one of them (clarithromycin or levofloxacin) is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus clarithromycin 0.5g bid or levofloxacin 0.5g qd will be prescribed.(4) When only metronidazole or none of them is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus tetracycline 0.4g qid will be prescribed.
干预措施: Levofloxacin (Drug)
Tailored Therapy
Medications will be adjusted according to clarithromycin，metronidazole and levofloxacin sensitivity. All drugs will be prescribed for 14 days.(1) When three of them or clarithromycin and metronidazole are sensitive, esomeprazole 20mg bid, clarithromycin 0.5g bid and metronidazole 0.4g bid will be prescribed. (2) When two of them (levofloxacin and clarithromycin or metronidazole) are sensitive, esomeprazole 20mg bid, levofloxacin 0.5g qd plus clarithromycin 0.5g bid or metronidazole 0.4g bid will be prescribed. (3) When one of them (clarithromycin or levofloxacin) is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus clarithromycin 0.5g bid or levofloxacin 0.5g qd will be prescribed.(4) When only metronidazole or none of them is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus tetracycline 0.4g qid will be prescribed.
干预措施: Tetracycline (Drug)
结局指标
主要结局
Helicobacter pylori eradication rate
时间窗: Six weeks after completion of therapy
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).
次要结局
- Rate of adverse effects(Within 7 days after completion of therapy)
- Compliance rate(Within 7 days after completion of therapy)
研究者
Hong Lu, MD
Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine
Shanghai Jiao Tong University School of Medicine