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Completed

NCT Number: NCT02978157

Levofloxacin Triple and Bismuth Quadruple Therapies for Rescue 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 EAL (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.) or EBTL (esomeprazole 40 mg b.d., bismuth 500 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.) therapy 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

  • positive results of both rapid urease test and histology,
  • a positive result of urea breath test,
  • or a positive result of culture.

Exclusion criteria

  • ingestion of antibiotics, bismuth, or proton pump inhibitor（PPI）within the prior 4 weeks,
  • patients with allergic history to the medications used,
  • patients with previous gastric surgery,
  • the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
  • pregnant women

Treatment and study plan

esomeprazole+amox+levo

Drug

esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.

Other names: esomeprazole 40 mg, amoxicillin 500 mg, levofloxacin 500 mg

esomeprazole+bismuth+tetra+levo

Drug

esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.

Other names: esomeprazole 40mg, bismuth 120 mg, tetracycline 500 mg, levofloxacin 500 mg

Primary outcomes

  1. Number of Participants in Which H. Pylori Was Eradicated

    Time frame: six weeks after the end of anti-H pylori therapy.

    Number of participants with negative H pylori status in follow-up tests as a measure of successful eradication

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

Registry information

Official study title

A Prospective Randomized Trial of Levofloxacin-amoxicillin Triple Therapy vs. Levofloxacin-tetracycline Quadruple Therapy in Second-line Helicobacter Pylori Treatment

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 30, 2016
Registry last updated
Mar 14, 2019

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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