Efficacies of Tetracycline-levofloxacin, Standard Bismuth, Amoxicillin-levofloxacin Quadruple Therapy for H.p

Last updated: April 28, 2023
Sponsor: Kaohsiung Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Helicobacter Pylori

Treatment

esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazole

esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacin

esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacin

Clinical Study ID

NCT05850117
KMUHIRB-F(I)-20190136
  • Ages > 20
  • All Genders

Study Summary

  1. Compare the efficacy of "Tetracycline combined with levofloxacin quadruple therapy", "standard tincture quadruple therapy" and "amoxicillin combined with levofloxacin quadruple therapy" on the second line of Helicobacter pylori sterilization.

  2. To investigate the drug resistance of Helicobacter pylori and the host genotypes of CYP2C19 and IL-1B-511 on the sterilizing effect of three second-line Helicobacter pylori.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. at least 20 years old
  2. subject was failure for the first line therapy of Helicobacter pylori

Exclusion

Exclusion Criteria:

  1. Those who are allergic to the drugs used in this study
  2. Those who have had a stomach surgery
  3. Those who have antibiotics within four weeks of treatment
  4. Those who have severe cirrhosis, uremia or malignancy
  5. Those who are a pregnant woman or a woman who breastfeeds

Study Design

Total Participants: 240
Treatment Group(s): 3
Primary Treatment: esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazole
Phase:
Study Start date:
February 10, 2020
Estimated Completion Date:
December 31, 2024

Study Description

The "standard tincture quadruple therapy" and the "proton pump inhibitor combined with fluoroquinolone and amoxicillin triple therapy" recommended by the 5th Mazdock-Florence Consensus Conference on the second line of Helicobacter pylori treatment The sterilization rate is not ideal (less than 80%). Recently, we have developed a "Tetracycline combined with levofloxacin quadruple therapy" for first-line treatment failure of H. pylori infection, with a relatively high sterilization rate (> 95%). A randomized controlled trial confirmed that the elimination rate of "Tetracycline combined with levofloxacin quadruple therapy" was better than "proton pump inhibitor combined with fluoroquinolone" after "standard triple therapy" and "non-tank tetratherapy" sterilization failure. Triple therapy with amoxicillin.

Connect with a study center

  • Kaohsiung Medical University Hospital

    Kaohsiung, 807
    Taiwan

    Active - Recruiting

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