Tailored Therapy for Helicobacter Pylori Rescue Treatment

Study Overview
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Brief Summary
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With increasing antibiotic resistance and unsatisfactory results of empiric eradication regimens, tailored therapy may be the best choice to achieve high efficacy for rescue treatment. This study aimed to evaluate the eradication rates, safety, and compliance of antimicrobial susceptibility-based tailored therapy for rescue treatment in patients with Helicobacter pylori infection.

Official Title
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Efficacy of Tailored for Helicobacter Pylori Rescue Treatment Based on Antimicrobial-susceptibility Testing

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: esomeprazole
* Drug: bismuth Potassium Citrate
* Drug: amoxicillin
* Drug: clarithromycin
* Drug: metronidazole
* Drug: levofloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease Previous failures of H. pylori eradication therapy and need rescue therapy Ability and willingness to participate in the study and to sign and give informed consent Confirmed H. pylori infection Exclusion Criteria: Less than 18 years old With previous gastric surgery Major systemic diseases Pregnancy or lactation Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored Therapy<br>After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole, amoxicillin and one sensitive of clarithromycin, metronidazole and levofloxacin.If isolates were resistant to all three tested antibiotics, give esomeprazole, bismuth potassium citrate, metronidazole and amoxicillin for 14 days. | Drug: esomeprazole<br>* proton pump inhibitor<br>Drug: bismuth Potassium Citrate<br>* gastric mucosal protective drug with anti-H. pylori effect<br>Drug: amoxicillin<br>* antibiotic for H. pylori eradication<br>Drug: clarithromycin<br>* antibiotic for H. pylori eradication<br>Drug: metronidazole<br>* antibiotic for H. pylori eradication<br>Drug: levofloxacin<br>* antibiotic for H. pylori eradication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori eradication rate | Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value). | Six weeks after completion of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse effects | The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as mild (transient and well tolerated), moderate (causing discomfort and partially interfering with daily activities), or severe (causing considerable interference with daily activities). | Within 7 days after completion of therapy | 
| Compliance rate | Compliance was defined as poor when they had taken less than 80% of the total medication. | Within 7 days after completion of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, Rescue therapy, Tailored therapy, Antimicrobial susceptibility testing