Clinical Efficacy and Health Economic Evaluation of Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment：Multicenter Randomized Controlled Study
Overview
- Phase
- Phase 4
- Intervention
- Esomeprazole
- Conditions
- Helicobacter Pylori Infection
- Sponsor
- Shanghai Zhongshan Hospital
- Enrollment
- 388
- Locations
- 3
- Primary Endpoint
- Eradication rate of Helicobacter pylori
- Last Updated
- 4 years ago
Overview
Brief Summary
This multicenter randomized controlled clinical trial was conducted to compare the eradication efficacy and health economic benefits of individualized regimens based on HP drug resistance mutation gene detection (multiple PCR method), individualized regimens based on HP traditional drug sensitivity testing (E-test method) and empirical regimens in the Helicobacter pylori treatment.
Detailed Description
This multicenter randomized controlled clinical trial was conducted to compare the eradication efficacy and health economic benefits of individualized regimens based on HP drug resistance mutation gene detection (multiple PCR method), individualized regimens based on HP traditional drug sensitivity testing (E-test method) and empirical regimens in the treatment of Helicobacter pylori in patients with chronic gastritis. This study will compare the efficacy of individualized and empirical drug sensitivity regimens, and conduct cost-effectiveness analysis to provide pharmacoeconomic guidance for clinical decision-making. At the same time, it will provide reference for the reasonable pricing of H.pylori drug sensitivity test and considering the health benefits brought by its inclusion in medical insurance.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
- •18-75 years old on the day of signing the ICF.
- •Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
Exclusion Criteria
- •Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
- •Subjects or guardians refused to participate in the trial.
- •Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
- •Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment.
- •Pregnant or lactating women.
- •Active peptic ulcer.
- •allergic to drugs used in the trial.
- •any other circumstances that are not suitable for recruitment.
Arms & Interventions
Genotypic resistance guided therapy
After Helicobacter pylori drug resistance mutation gene detection, according to genotypic antibiotic resistance pattern of each one, give esomeprazole 20mg bid and bismuth potassium citrate 0.6 g bid, combined two sensitive antibiotics of Amoxicillin, tetracycline,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Intervention: Esomeprazole
Genotypic resistance guided therapy
After Helicobacter pylori drug resistance mutation gene detection, according to genotypic antibiotic resistance pattern of each one, give esomeprazole 20mg bid and bismuth potassium citrate 0.6 g bid, combined two sensitive antibiotics of Amoxicillin, tetracycline,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Intervention: Bismuth potassium citrate
Genotypic resistance guided therapy
After Helicobacter pylori drug resistance mutation gene detection, according to genotypic antibiotic resistance pattern of each one, give esomeprazole 20mg bid and bismuth potassium citrate 0.6 g bid, combined two sensitive antibiotics of Amoxicillin, tetracycline,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Intervention: Metronidazole
Genotypic resistance guided therapy
After Helicobacter pylori drug resistance mutation gene detection, according to genotypic antibiotic resistance pattern of each one, give esomeprazole 20mg bid and bismuth potassium citrate 0.6 g bid, combined two sensitive antibiotics of Amoxicillin, tetracycline,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Intervention: Clarithromycin
Genotypic resistance guided therapy
After Helicobacter pylori drug resistance mutation gene detection, according to genotypic antibiotic resistance pattern of each one, give esomeprazole 20mg bid and bismuth potassium citrate 0.6 g bid, combined two sensitive antibiotics of Amoxicillin, tetracycline,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Intervention: Levofloxacin
Genotypic resistance guided therapy
After Helicobacter pylori drug resistance mutation gene detection, according to genotypic antibiotic resistance pattern of each one, give esomeprazole 20mg bid and bismuth potassium citrate 0.6 g bid, combined two sensitive antibiotics of Amoxicillin, tetracycline,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Intervention: Amoxicillin
Genotypic resistance guided therapy
After Helicobacter pylori drug resistance mutation gene detection, according to genotypic antibiotic resistance pattern of each one, give esomeprazole 20mg bid and bismuth potassium citrate 0.6 g bid, combined two sensitive antibiotics of Amoxicillin, tetracycline,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Intervention: Tetracycline
Phenotypic resistance guided therapy
After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to phenotypic antibiotic resistance pattern of each one, give esomeprazole 20mg bid and bismuth potassium citrate 0.6 g bid, combined two sensitive antibiotics of Amoxicillin, tetracycline,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Intervention: Esomeprazole
Phenotypic resistance guided therapy
After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to phenotypic antibiotic resistance pattern of each one, give esomeprazole 20mg bid and bismuth potassium citrate 0.6 g bid, combined two sensitive antibiotics of Amoxicillin, tetracycline,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Intervention: Bismuth potassium citrate
Phenotypic resistance guided therapy
After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to phenotypic antibiotic resistance pattern of each one, give esomeprazole 20mg bid and bismuth potassium citrate 0.6 g bid, combined two sensitive antibiotics of Amoxicillin, tetracycline,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Intervention: Metronidazole
Phenotypic resistance guided therapy
After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to phenotypic antibiotic resistance pattern of each one, give esomeprazole 20mg bid and bismuth potassium citrate 0.6 g bid, combined two sensitive antibiotics of Amoxicillin, tetracycline,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Intervention: Clarithromycin
Phenotypic resistance guided therapy
After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to phenotypic antibiotic resistance pattern of each one, give esomeprazole 20mg bid and bismuth potassium citrate 0.6 g bid, combined two sensitive antibiotics of Amoxicillin, tetracycline,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Intervention: Levofloxacin
Phenotypic resistance guided therapy
After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to phenotypic antibiotic resistance pattern of each one, give esomeprazole 20mg bid and bismuth potassium citrate 0.6 g bid, combined two sensitive antibiotics of Amoxicillin, tetracycline,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Intervention: Amoxicillin
Phenotypic resistance guided therapy
After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to phenotypic antibiotic resistance pattern of each one, give esomeprazole 20mg bid and bismuth potassium citrate 0.6 g bid, combined two sensitive antibiotics of Amoxicillin, tetracycline,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Intervention: Tetracycline
Empiric therapy
Esomeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g bid (no penicillin allergy) OR tetracycline 0.5g qid (penicillin allergy) for 14 days
Intervention: Esomeprazole
Empiric therapy
Esomeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g bid (no penicillin allergy) OR tetracycline 0.5g qid (penicillin allergy) for 14 days
Intervention: Bismuth potassium citrate
Empiric therapy
Esomeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g bid (no penicillin allergy) OR tetracycline 0.5g qid (penicillin allergy) for 14 days
Intervention: Metronidazole
Empiric therapy
Esomeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g bid (no penicillin allergy) OR tetracycline 0.5g qid (penicillin allergy) for 14 days
Intervention: Amoxicillin
Empiric therapy
Esomeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g bid (no penicillin allergy) OR tetracycline 0.5g qid (penicillin allergy) for 14 days
Intervention: Tetracycline
Outcomes
Primary Outcomes
Eradication rate of Helicobacter pylori
Time Frame: 6 weeks
Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value).
Secondary Outcomes
- Eradication rate of Helicobacter pylori susceptible strains(6 weeks)
- Eradication rate of Helicobacter pylori resistant strains(6 weeks)