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

Ping-I (William) Hsu, M.D.

Status: Completed

Conditions: Helicobacter Pylori Infection

Treatments: Drug: 10d TL quadruple therapy; Drug: 10d AL quadruple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03779087

VGHKS18-CT7-22

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 112 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

10d TL quadruple therapy

Experimental group

Description:

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

Treatment:

Drug: 10d TL quadruple therapy

10d AL quadruple therapy

Active Comparator group

Description:

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

Treatment:

Drug: 10d AL quadruple therapy