Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection

Overview

From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.

Full Title of Study: “Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection – a Multi-center Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2020

Detailed Description

The H pylori-infected adult patients with failure of standard triple therapy and H pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly assigned to either TL quadruple therapy (esomeprazole-bismuth-tetracycline-levofloxacin regimen) or AL quadruple therapy (esomeprazole-bismuth-amoxicillin-levofloxacin regimen) for 10 days. Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests is performed at six weeks after the end of anti-H pylori therapy.

Interventions

  • Drug: 10d TL quadruple therapy
    • esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, tetracycline 500 mg qid, levofloxacin 500 mg qd.
  • Drug: 10d AL quadruple therapy
    • esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, amoxicillin 500 mg qid, levofloxacin 500 mg qd.

Arms, Groups and Cohorts

  • Experimental: 10d TL quadruple therapy
    • esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days
  • Active Comparator: 10d AL quadruple therapy
    • esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, amoxicillin 500 mg and metronidazole 250 mg q.i.d. for 10 days

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants in Which H. Pylori Was Eradicated
    • Time Frame: sixth week after the end of anti- H. pylori therapy
    • To assess eradication efficacy,repeated endoscopy with rapid urease test, histological

Participating in This Clinical Trial

Inclusion Criteria

  • Consecutive H pylori-infected outpatients, at least 20 years of age with failure of first-line eradication treatments (standard triple, non-bismuth quadruple and bismuth quadruple therapies) Exclusion Criteria:

  • previous allergic reactions to the study medications, – history of gastrectomy, – use of antibiotics within the previous 4 weeks, – pregnant or lactating women, – coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia, and malignancy).

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ping-I (William) Hsu, M.D.
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Ping-I (William) Hsu, M.D., Professor – Kaohsiung Veterans General Hospital.
  • Overall Official(s)
    • Ping-I Hsu, Bachelor, Study Chair, Kaohsiung Veterans General Hospital.

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