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

Fudan University

Status and phase: Unknown; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Clarithromycin; Drug: Bismuth potassium citrate; Drug: Metronidazole; Drug: Rabeprazole; Drug: Levofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT05023577

B2021-3762

Details and patient eligibility

About

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.

Enrollment: 504 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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504 participants in 3 patient groups

CL group

Experimental group

Description:

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

Treatment:

Drug: Clarithromycin

Drug: Bismuth potassium citrate

Drug: Levofloxacin

Drug: Rabeprazole

LM group

Experimental group

Description:

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

Treatment:

Drug: Bismuth potassium citrate

Drug: Levofloxacin

Drug: Metronidazole

Drug: Rabeprazole

CM group

Active Comparator group

Description:

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

Treatment:

Drug: Clarithromycin

Drug: Bismuth potassium citrate

Drug: Metronidazole

Drug: Rabeprazole