Comparing the Efficacy of Hybrid, High-dose Dual and Bismuth Quadruple Therapies

Phase 3

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: 10d bismuth quadruple therapy; Drug: 14D high-dose dual therapy; Drug: 14d hybrid therapy

• Registration Number: NCT03779074
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief Summary

Both hybrid and high-dose dual therapies developed by the scholars from Taiwan can achieve a high eradication rate for clarithromycin-resistant strains, and have a great potential to replace bismuth quadruple therapy in the treatment of H. pylori infection.

Detailed Description

Bismuth quadruple therapy has been recommended as a choice of the first-line treatment for H. pylori infection in several important international consensuses. However, it is associated with a high frequency of adverse events. Both hybrid and high-dose dual therapies developed by the scholars from Taiwan can achieve a high eradication rate for clarithromycin-resistant strains, and have a great potential to replace bismuth quadruple therapy in the treatment of H. pylori infection. In the second-line treatment, tetracycline-levofloxacin quadruple therapy developed by our study group can achieve a higher eradication rate than levofloxacin triple therapy for salvage treatment of hybrid therapy. However, whether the new therapy can be a promising rescue treatment for bismuth quadruple or high-dose dual therapy remains unanswered.

Study Timeline

• Study Start: 2018-09-03
• Study First Submitted: 2018-12-16
• Study First Submitted QC: 2018-12-16
• Study First Posted: 2018-12-19
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 918

Inclusion Criteria

• Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria

• previous H pylori-eradication therapy
• ingestion of antibiotics or bismuth within the prior 4 weeks
• patients with allergic history to the medications used
• patients with previous gastric surgery
• the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
• pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10d bismuth quadruple therapy	10d bismuth quadruple therapy	rabeprazole 20 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days.
14d high-dose dual therapy	14D high-dose dual therapy	rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days
14d hybrid therapy	14d hybrid therapy	a dual regimen with rabeprazole 20 mg and amoxicillin 1 g b.i.d. for 7 days followed by a quadruple regimen with rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg b.i.d. for 7 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 with urea breath test

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan