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

Shanghai Zhongshan Hospital504 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

504

Conditions

Helicobacter Pylori Infection

Interventions

RabeprazoleDRUG

20mg bid

Bismuth potassium citrateDRUG

0.6g bid

MetronidazoleDRUG

0.4g qid

Clarithromycin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Eradication rate of Helicobacter pylori

Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value).

Time frame: At least 4 weeks after completion of therapy

Secondary Outcomes

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.

Time frame: 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.

Time frame: At least 4 weeks after completion of therapy

Central Contacts

Qi Chen, MD

CONTACT

86-17811921405 chenqimd@163.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.