High Dose Amoxicillin Versus Tetracycline as Second-line Treatment of Resistant Helicobacter Pylori Infection

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-10-31

Brief Summary

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No trial has examined the the efficacy of high dose amoxicillin based quadruple therapy as second-line treatment for Helicobacter pylori infection. The study aims to compare the effectiveness and safety of 14-day high dose amoxicillin-based quadruple regiment with classical quadruple regiment for rescue eradication of Helicobacter pylori.

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Detailed Description

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Helicobacter pylori is the most successful human pathogen infecting an estimated 50% of the global population, and is associated with a spectrum of disease states, including chronic gastritis, duodenal and gastric ulcer, gastric adenocarcinoma, and gastric mucosa-associated lymphoid tissue lymphoma (MALToma).

Most Consensus Conferences and Clinical Guidelines recommend the prescription of a triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole, as first-line treatment. However, the effectiveness of these triple-therapy regimens seems to have diminished over time, largely as a result of emerging resistance of the organism to clarithromycin. Avoiding problems due to antibiotic resistance has become an important issue when deciding a second-line rescue therapy for H. pylori infection

Bismuth-containing quadruple therapies have been used widely in second-line therapy of H. pylori infection, and are recommended by the Maastricht IV Consensus Conference report. Quadruple therapy can achieve a high rate of eradication success as a second-line treatment. A meta-analysis of quadruple therapy showed that metronidazole resistance had limited effect on the outcome when adequate dosages and durations are used. This meta-analysis also showed that compliance with quadruple therapy is high. Classical bismuth-based quadruple therapy consists of a PPI, bismuth, tetracycline and metronidazole. This regiment meets the proposed criteria for a second-line treatment: it does not contain the key antibiotic of the original regimen (clarithromycin), the treatment is not affected by clarithromycin resistance, metronidazole resistance in vitro does not affect the outcome of quadruple therapy significantly, compliance with the regimen is high and the regimen is effective in most parts of the world. But this regiment has high rate of side effects because of tetracycline.

Amoxicillin has low resistance rate as well as low percentage of side effects. The replacement of tetracycline by high dose amoxicillin in classical bismuth-containing quadruple therapy may be a better choice. Therefore, we will do a randomized trial to compare the eradication rate of 14-day high dose amoxicillin and metronidazole based bismuth-containing quadruple therapy with classical quadruple therapy for second-line Helicobacter pylori treatment.

Conditions

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Helicobacter Pylori Treatment Failure

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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High Dose Amoxicillin

High dose amoxicillin/metronidazole-based quadruple therapy for 14 days: Lansoprazole 30mg bid, Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg tid, Metronidazole 400mg qid

Group Type EXPERIMENTAL

Lansoprazole

Intervention Type DRUG

antisecretory drug of each quadruple therapy

Bismuth Potassium Citrate

Intervention Type DRUG

one component of each quadruple therapy

Metronidazole

Intervention Type DRUG

antibiotic of each quadruple therapy

Amoxicillin

Intervention Type DRUG

antibiotic of high dose amoxicillin based quadruple therapy

Tetracycline

Classical quadruple therapy for 14 days: Lansoprazole 30mg bid, Bismuth Potassium Citrate 220mg bid, Tetracycline 500mg qid, Metronidazole 400mg qid

Group Type ACTIVE_COMPARATOR

Lansoprazole

Intervention Type DRUG

antisecretory drug of each quadruple therapy

Bismuth Potassium Citrate

Intervention Type DRUG

one component of each quadruple therapy

Metronidazole

Intervention Type DRUG

antibiotic of each quadruple therapy

Tetracycline

Intervention Type DRUG

antibiotic of classical quadruple therapy

Interventions

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Lansoprazole

antisecretory drug of each quadruple therapy

Intervention Type DRUG

Bismuth Potassium Citrate

one component of each quadruple therapy

Intervention Type DRUG

Metronidazole

antibiotic of each quadruple therapy

Intervention Type DRUG

Amoxicillin

antibiotic of high dose amoxicillin based quadruple therapy

Intervention Type DRUG

Tetracycline

antibiotic of classical quadruple therapy

Intervention Type DRUG

Other Intervention Names

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proton pump inhibitor Bismuth antibiotic antibiotic antibiotic

Eligibility Criteria

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Inclusion Criteria

* all patients had failed H.pylori therapies including clarithromycin, metronidazole and/or amoxicillin (if not allergic) before
* indication of rescue H pylori eradication treatment
* Ability and willingness to participate in the study and to sign and give informed consent

Exclusion Criteria

* patients less than 18 years old
* previous gastric surgery
* pregnancy or lactation
* major systemic diseases,
* administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks
* allergy to any one of the medication used in the quadruple regimens.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No