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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    504
  • sponsor
    Shanghai Zhongshan Hospital
Updated on 22 September 2021

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.

Details
Condition H. Pylori Infection, Helicobacter Pylori Infection
Treatment levofloxacin, clarithromycin, metronidazole, Rabeprazole, Bismuth Potassium Citrate
Clinical Study IdentifierNCT05023577
SponsorShanghai Zhongshan Hospital
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF)
-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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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