Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H 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

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-11

Study Completion Date

2020-06-30

Brief Summary

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From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.

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Detailed Description

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The H pylori-infected adult patients with failure of standard triple therapy and H pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly assigned to either TL quadruple therapy (esomeprazole-bismuth-tetracycline-levofloxacin regimen) or AL quadruple therapy (esomeprazole-bismuth-amoxicillin-levofloxacin regimen) for 10 days. Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests is performed at six weeks after the end of anti-H pylori therapy.

Conditions

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Helicobacter Pylori Infection

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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10d TL quadruple therapy

esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days

Group Type EXPERIMENTAL

10d TL quadruple therapy

Intervention Type DRUG

esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, tetracycline 500 mg qid, levofloxacin 500 mg qd.

10d AL quadruple therapy

esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, amoxicillin 500 mg and metronidazole 250 mg q.i.d. for 10 days

Group Type ACTIVE_COMPARATOR

10d AL quadruple therapy

Intervention Type DRUG

esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, amoxicillin 500 mg qid, levofloxacin 500 mg qd.

Interventions

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10d TL quadruple therapy

esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, tetracycline 500 mg qid, levofloxacin 500 mg qd.

Intervention Type DRUG

10d AL quadruple therapy

esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, amoxicillin 500 mg qid, levofloxacin 500 mg qd.

Intervention Type DRUG

Other Intervention Names

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esomeprazole 40 mg tripotassium dicitrate bismuthate 300mg tetracycline 500 mg levofloxacin 500 mg esomeprazole 40 mg tripotassium dicitrate bismuthate 300mg amoxicillin 500 mg levofloxacin 500 mg

Eligibility Criteria

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Inclusion Criteria

* Consecutive H pylori-infected outpatients, at least 20 years of age with failure of first-line eradication treatments (standard triple, non-bismuth quadruple and bismuth quadruple therapies)

Exclusion Criteria

* previous allergic reactions to the study medications,
* history of gastrectomy,
* use of antibiotics within the previous 4 weeks,
* pregnant or lactating women,
* coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia, and malignancy).

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No