Development of Treatment Algorithm for Eradication of Helicobacter Pylori Based on Antibiotic Susceptibility Test

April 28, 2016 updated by: Jie hyun Kim, Gangnam Severance Hospital
Helicobacter pylori eradication (H. pylori) rates with clarithromycin-based triple therapy are declining, and an alternative strategy is needed urgently. The investigators sought to compare the efficacy of pretreatment antimicrobial susceptibility-guided vs. clarithromycin-based triple therapy vs. concomitant therapy for H. pylori eradication in a region with high rates of multiple drug resistance.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135720
        • Recruiting
        • Gangnam Severance Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. positive results of rapid urease test

Exclusion Criteria:

  1. liver cirrhosis,
  2. chronic kidney disease,
  3. bleeding tendency,
  4. pregnant,
  5. allergy to antibiotics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Susceptibility-guided group
Drugs according to antimicrobial susceptibility-guided treatment
Drug: eradication of Helicobacter pylori

clarithromycin-based triple therapy Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk

  • concomitant therapy group Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk Metronidazole 500mg, PO, BID, 1wk
  • bismuth based quadraple therapy Pantoloc 40mg, PO, BID, 1wk Bismuth, 300mg, PO, QID, 1wk Tetracycline, 500mg, PO, QID, 1wk Metronidazole, 500mg, PO, TID, 1wk
  • levofloxacine based triple therapy Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Levofloxacin 500mg, PO, QD, 1wk
Sham Comparator: triple therapy group
Drugs - Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk
Drug: eradication of Helicobacter pylori

clarithromycin-based triple therapy Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk

  • concomitant therapy group Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk Metronidazole 500mg, PO, BID, 1wk
  • bismuth based quadraple therapy Pantoloc 40mg, PO, BID, 1wk Bismuth, 300mg, PO, QID, 1wk Tetracycline, 500mg, PO, QID, 1wk Metronidazole, 500mg, PO, TID, 1wk
  • levofloxacine based triple therapy Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Levofloxacin 500mg, PO, QD, 1wk
Sham Comparator: concomitant therapy group
Drugs - Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk Metronidazole 500mg, PO, BID, 1wk
Drug: eradication of Helicobacter pylori

clarithromycin-based triple therapy Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk

  • concomitant therapy group Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk Metronidazole 500mg, PO, BID, 1wk
  • bismuth based quadraple therapy Pantoloc 40mg, PO, BID, 1wk Bismuth, 300mg, PO, QID, 1wk Tetracycline, 500mg, PO, QID, 1wk Metronidazole, 500mg, PO, TID, 1wk
  • levofloxacine based triple therapy Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Levofloxacin 500mg, PO, QD, 1wk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
eradication rate of Helicobacter pylori
Time Frame: the H. pylori status was checked 4 weeks aft er the end of treatment using the 13 C-urea breath test.
the H. pylori status was checked 4 weeks aft er the end of treatment using the 13 C-urea breath test.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Estimate)

May 3, 2016

Last Update Submitted That Met QC Criteria

April 28, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2015-0193

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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