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

Kaohsiung Veterans General Hospital

Status and phase: Completed; Phase 3

Conditions: Helicobacter Pylori Infection

Treatments: Drug: 14d hybrid therapy; Drug: 14D high-dose dual therapy; Drug: 10d bismuth quadruple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03779074

VGHKS18-CT4-24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 918 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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918 participants in 3 patient groups

10d bismuth quadruple therapy

Active Comparator group

Description:

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.

Treatment:

Drug: 10d bismuth quadruple therapy

14d hybrid therapy

Experimental group

Description:

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.

Treatment:

Drug: 14d hybrid therapy

14d high-dose dual therapy

Experimental group

Description:

rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days

Treatment:

Drug: 14D high-dose dual therapy