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

Study Overview
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Brief Summary
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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.

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

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: eradication of Helicobacter pylori


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. positive results of rapid urease test Exclusion Criteria: liver cirrhosis, chronic kidney disease, bleeding tendency, pregnant, allergy to antibiotics

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Susceptibility-guided group<br>Drugs according to antimicrobial susceptibility-guided treatment | Drug: eradication of Helicobacter pylori<br>* 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<br>|
| Sham Comparator: triple therapy group<br>Drugs - Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk | Drug: eradication of Helicobacter pylori<br>* 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<br>|
| Sham Comparator: concomitant therapy group<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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