Antibiotic Combination for H. Pylori Eradication in Penicillin-allergic Patients

Study Overview
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Brief Summary
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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.

Official Title
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Clarithromycin-, Metronidazole-, or Levofloxacin-containing Therapy for Helicobacter Pylori-infected Penicillin-allergic Patients: A Randomized Controlled Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Rabeprazole
* Drug: Bismuth potassium citrate
* Drug: Metronidazole
* Drug: Clarithromycin
* Drug: Levofloxacin


Participation Criteria
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Eligibility Criteria
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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. Have not received Helicobacter pylori eradication treatment before. allergic to penicillin. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CL group<br>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 | Drug: Rabeprazole<br>* 20mg bid<br>Drug: Bismuth potassium citrate<br>* 0.6g bid<br>Drug: Clarithromycin<br>* 0.5g bid<br>Drug: Levofloxacin<br>* 0.5g qd<br>|
| Experimental: LM group<br>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 | Drug: Rabeprazole<br>* 20mg bid<br>Drug: Bismuth potassium citrate<br>* 0.6g bid<br>Drug: Metronidazole<br>* 0.4g qid<br>Drug: Levofloxacin<br>* 0.5g qd<br>|
| Active Comparator: CM group<br>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 | Drug: Rabeprazole<br>* 20mg bid<br>Drug: Bismuth potassium citrate<br>* 0.6g bid<br>Drug: Metronidazole<br>* 0.4g qid<br>Drug: Clarithromycin<br>* 0.5g bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate of Helicobacter pylori | Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). | At least 4 weeks after completion of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate of Helicobacter pylori resistant strains | 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. | At least 4 weeks after completion of therapy | 
| Eradication rate of Helicobacter pylori susceptible strains | 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. | At least 4 weeks after completion of therapy |