Antibiotic Combination for H. Pylori Eradication in Penicillin-allergic Patients
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Registration Number
- NCT05023577
- Lead Sponsor
- Shanghai Zhongshan Hospital
- Brief Summary
This randomized controlled clinical trial will compare the eradication efficacy of bismuth quadruple therapy containing clarithromycin+metronidazole, clarithromycin+levofloxacin, or metronidazole+levofloxacin for Helicobacter pylori first-line treatment in penicillin-allergic patients. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 504
- 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.
- Have not received Helicobacter pylori eradication treatment before.
- allergic to penicillin.
- Have received Hp eradication treatment.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CL group Clarithromycin Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levoflaxacin 0.5 g qd for 14 days CL group Levofloxacin Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levoflaxacin 0.5 g qd for 14 days LM group Rabeprazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levoflaxacin 0.5 g bid for 14 days CL group Rabeprazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levoflaxacin 0.5 g qd for 14 days LM group Metronidazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levoflaxacin 0.5 g bid for 14 days CM group Clarithromycin Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days CL group Bismuth potassium citrate Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levoflaxacin 0.5 g qd for 14 days LM group Bismuth potassium citrate Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levoflaxacin 0.5 g bid for 14 days CM group Bismuth potassium citrate Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days LM group Levofloxacin Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levoflaxacin 0.5 g bid for 14 days CM group Rabeprazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days CM group Metronidazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days
- Primary Outcome Measures
Name Time Method Eradication rate of Helicobacter pylori At least 4 weeks after completion of therapy Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value).
- Secondary Outcome Measures
Name Time Method Eradication rate of Helicobacter pylori susceptible strains At least 4 weeks after completion of therapy Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value). The antibiotic susceptible strains were assessed using the E test method.
Eradication rate of Helicobacter pylori resistant strains At least 4 weeks after completion of therapy Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value). The antibiotic resistant strains were assessed using the E test method.
Trial Locations
- Locations (1)
Zhongshan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China