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

Not Applicable

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: 10d AL quadruple therapy; Drug: 10d TL quadruple therapy

• Registration Number: NCT03779087
• Lead Sponsor: Ping-I (William) Hsu, M.D.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-07-11
• Study First Submitted: 2018-12-16
• Study First Submitted QC: 2018-12-16
• Study First Posted: 2018-12-19
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10d AL quadruple therapy	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
10d TL quadruple therapy	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

Primary Outcome Measures

Name	Time	Method
Number of Participants in Which H. Pylori Was Eradicated	sixth week after the end of anti- H. pylori therapy	To assess eradication efficacy,repeated endoscopy with rapid urease test, histological

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan