The Efficacy of the 7 Days Tailored Therapy as the 1st Eradication of H. Pylori Infection

Study Overview
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Brief Summary
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To compare the eradication success rate between 10-days sequential therapy and 7-days tailored therapy based on H. pylori culture and antimicrobial susceptibility testing.

Detailed Description
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As increasing antimicrobial resistance in Korea, the effectiveness of empirical Helicobacter pylori (H. pylori) therapies have been declined. Recently, 10-day sequential therapy was not sufficient to overcome tough situation for H. pylori eradication. Thus, in this study, the investigators evaluated the efficacy of H. pylori eradication between a 7 days tailored therapy (7 day PPI based triple therapy, bismuth quadruple therapy or moxifloxacin contained triple therapy) for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 10 day sequential therapy for the first eradication of H. pylori infection, and the investigators analyzed the prevalence of the antibiotic resistance in the tailored therapy group.

Official Title
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A Prospective, Single-center, Open-label, Clinical Trial to Compare the 10-day Sequential Therapy and 7-day Culture Based Tailored Therapy for the Eradication of Helicobacter Pylori

Conditions
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Helicobacter Infection

Intervention / Treatment
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* Drug: 10 day sequential therapy (Esomeprazole, amoxicillin, clarithromycin, metronidazole)
* Drug: 7 day tailored PPI triple therapy (clarithromycin-containing triple therapy)
* Drug: 7 day moxifloxacin based triple therapy [Esomeprazole, Moxifloxacin, Amoxicillin]
* Drug: 7 or 14 days tailored EBMT therapy group (bismuth quadruple therapy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients who proved H. pylori infection following three methods positive rapid urease test (CLOtest) histologic evidence of H. pylori by modified Giemsa staining positive Urea breath test Male and female Korean Adult (Aged ≥ 18 years) Exclusion Criteria: Patients who received eradication therapy for H. pylori infection, previously H. pylori eradication failure because of poor compliance the administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks Advanced gastric cancer or other malignancy Abnormal liver function or liver cirrhosis Abnormal renal function or chronic kidney disease Other severe concurrent diseases Previous allergic reactions to the study drugs Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients selected study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10 day sequential group<br>After proving H. pylori infection, the participant will receive the empirical 10 day sequential regimen (Esomeprazole, nexium® 40 mg bid 10 days (D1-D10)+amoxicillin® 1 g bid 5 days (D1-D5)+clarithromycin, klaricid® 500mg bid 5 days (D6-D10)+metronidazole, flasinyl® 500mg tid 5 days (D6-D10) for treatment of H. pylori infection in this group. | Drug: 10 day sequential therapy (Esomeprazole, amoxicillin, clarithromycin, metronidazole)<br>* In this group, patients will receive the 10 day sequential regimen for eradication of H. pylori. 10 day sequential regimen is like follows; Esomeprazole 40 mg bid 10 days (D1-D10)+amoxicillin 1 g bid 5 days (D1-D5)+clarithromycin 500 mg bid 5 days (D6-D10)+metronidazole 500 mg tid 5 days (D6-D10).<br>|
| Experimental: 7 days tailored PPI triple therapy group<br>After proving H. pylori infection, the participant received endoscopic guided biopsy for H. pylori culture and MIC. Based on antimicrobial susceptibility testing, the participant will receive 7 day tailored regimen [PPI triple therapy (Esomeprazole, nexium® 40 mg bid 7 days (D1-D7)+amoxicillin® 1 g bid 7 days (D1-D7)+clarithromycin, klaricid® 500mg bid 7 days (D1-D7)] in this group. | Drug: 7 day tailored PPI triple therapy (clarithromycin-containing triple therapy)<br>* the participants received PPI based triple therapy[Esomeprazole 40 mg bid 7 days (D1-D7)+amoxicillin 1000mg bid 7 days (D1-D7)+clarithromycin 500mg bid 7 days (D1-D7)]<br>* Other names: 7d PPI triple therapy;|
| Experimental: 7 days tailored MEA therapy group<br>After proving H. pylori infection, the participant received endoscopic guided biopsy for H. pylori culture and MIC. Based on antimicrobial susceptibility testing, the participant will receive 7 day moxifloxacin triple therapy [Esomeprazole, nexium® 40 mg bid 7 days (D1-D7)+Moxifloxacin, avelox® 400 mg qd 7 days (D1-D7)+Amoxicillin® 1 g bid 7 days (D1-D7)] in this group. | Drug: 7 day moxifloxacin based triple therapy [Esomeprazole, Moxifloxacin, Amoxicillin]<br>* moxifloxacin triple therapy [Esomeprazole, 40 mg bid 7 days (D1-D7)+Moxifloxacin, 400 mg qd 7 days (D1-D7)+Amoxicillin 1 g bid 7 days (D1-D7)].<br>* Other names: 7d MEA triple therapy;|
| Experimental: 7 or 14 days tailored EBMT therapy group<br>After proving H. pylori infection, the participant received endoscopic guided biopsy for H. pylori culture and MIC. Based on antimicrobial susceptibility testing, the participant will receive 7 day bismuth quadruple therapy [Esomeprazole, nexium® 40 mg bid 7 days (D1-D7)+Tri potassium dicitrate bismuthate, denol® 300 mg qid 7 days (D1-D7)+Metronidazole, flasinyl® 500 mg tid 7 days (D1-D7)+Tetracycline® 500 mg qid 7 days (D1-D7)] in this group. If there was no metronidazole resistance, the treatment was 7 days in duration. If metronidazole resistance was evident, treatment duration was 14 days. | Drug: 7 or 14 days tailored EBMT therapy group (bismuth quadruple therapy)<br>* bismuth quadruple therapy [Esomeprazole, 40 mg bid 7 days (D1-D7)+amoxicillin 1 g bid 7 days (D1-D7)+clarithromycin 500mg bid 7 days (D1-D7)], bismuth quadruple therapy [Esomeprazole, 40 mg bid 7 days (D1-D7)+Tri potassium dicitrate bismuthate, 300 mg qid 7 days (D1-D7)+Metronidazole, 500 mg tid 7 days (D1-D7)+Tetracycline 500 mg qid 7 days (D1-D7)] If there was no metronidazole resistance, the treatment was 7 days in duration. If metronidazole resistance was evident, treatment duration was 14 days.<br>* Other names: 7d or 14d quadruple therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the percentage of participants with successful H. pylori eradication in each groups | The efficacy of H. pylori eradication between a 7 days tailored therapy for H. pylori infection based on the results of antimicrobial resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 10 days therapy as first eradication regimen. | 6 weeks after completion of eradication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, tailored therapy, eradication