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Completed

NCT Number: NCT03779087

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

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

10d TL quadruple therapy

Drug

esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, tetracycline 500 mg qid, levofloxacin 500 mg qd.

Other names: esomeprazole 40 mg, tripotassium dicitrate bismuthate 300mg, tetracycline 500 mg, levofloxacin 500 mg

10d AL quadruple therapy

Drug

esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, amoxicillin 500 mg qid, levofloxacin 500 mg qd.

Other names: esomeprazole 40 mg, tripotassium dicitrate bismuthate 300mg, amoxicillin 500 mg, levofloxacin 500 mg

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ping-I (William) Hsu, M.D.

Other

Registry information

Official study title

Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection - a Multi-center Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 19, 2018
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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