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

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT02373280

Collaborator

(none)

600

Enrollment

Location

Arms

100

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Infection	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)	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients selected studyPatients selected study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 10 day sequential group 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) 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).
Experimental: 7 days tailored PPI triple therapy group 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) 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)] Other Names: 7d PPI triple therapy
Experimental: 7 days tailored MEA therapy group 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] 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)]. Other Names: 7d MEA triple therapy
Experimental: 7 or 14 days tailored EBMT therapy group 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) 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. Other Names: 7d or 14d quadruple therapy

Outcome Measures

Primary Outcome Measures

Compare the percentage of participants with successful H. pylori eradication in each groups [6 weeks after completion of eradication]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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
1. 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