Genotypic Resistance Guided Therapy in Helicobacter Pylori Eradication

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2017-12-31

Brief Summary

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We aimed to compare the efficacy of genotypic resistance guided sequential therapy vs. empiric therapy in the third line therapy. Factors affecting the eradication rates, including the antibiotic resistance, CYP2C19 polymorphism, CagA and VacA status will also be assessed.

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Detailed Description

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The primary aim of this study is to compare the regimens selected using either one of the method (1) genotypic resistance guided versus (2) medication history guided therapy. (rather than to compare the efficacy of any drugs).

Conditions

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Self Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Empirical therapy

selection of antibiotic according to medication history

Group Type ACTIVE_COMPARATOR

empirical therapy

Intervention Type DRUG

1. Nexium (esomeprazole), 40mg, bid, 14 days, plus
2. Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus
3. Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs
4. Select either one of the drugs according to medication history Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14

Genotypic resistance guided therapy

selection of antibiotics according to genotypic resistance

Group Type EXPERIMENTAL

Genotypic resistance guided therapy

Intervention Type DRUG

1. Nexium (esomeprazole), 40mg, bid, 14 days, plus
2. Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus
3. Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs
4. Select either one of the drugs according to genotypic resistance results Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14

Interventions

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empirical therapy

1. Nexium (esomeprazole), 40mg, bid, 14 days, plus
2. Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus
3. Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs
4. Select either one of the drugs according to medication history Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14

Intervention Type DRUG

Genotypic resistance guided therapy

1. Nexium (esomeprazole), 40mg, bid, 14 days, plus
2. Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus
3. Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs
4. Select either one of the drugs according to genotypic resistance results Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14

Intervention Type DRUG

Other Intervention Names

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selection of antibiotics according to medication history selection of antibiotic according to genotypic resistance

Eligibility Criteria

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Inclusion Criteria

* Patients aged greater than 20 years who have persistent H. pylori infection after at least two treatments and are willing to receive third line rescue regimens are considered eligible for enrollment.

Exclusion Criteria

* Patients will be excluded from the study if any one of the following criteria is present: (1) children and teenagers aged less than 20 years, (2) history of gastrectomy, (3)gastric malignancy, including adenocarcinoma and lymphoma, (4) previous allergic reaction to antibiotics (Amoxicillin, Klaricid, Cravit) and prompt pump inhibitors (esomeprazole), (5)contraindication to treatment drugs, (6) pregnant or lactating women, (7) severe concurrent disease.

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No