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

Efficacies of Hybrid, High-dose Dual and Bismuth Quadruple Therapies for the First-line Anti-H Pylori Treatment and Tetracycline-levofloxacin Quadruple Therapy for the Second-line Anti-H Pylori Treatment - a Multicentre Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: 10d bismuth quadruple therapy; Drug: 14d hybrid therapy; Drug: 14D high-dose dual therapy

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 Type: Interventional
• Enrollment (Actual): 918
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 813
    • Kaohsiung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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; Other Names: rabeprazole 20 mg bid; tripotassium dicitrate bismuthate 300mg qid; tetracycline 500 mg qid; metronidazole 250 mg qid
Experimental: 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.	Drug: 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; Other Names: rabeprazole 20 mg bid; amoxicillin 1 g bid; clarithromycin 500 mg bid; metronidazole 500 mg bid
Experimental: 14d high-dose dual therapy; rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days	Drug: 14D high-dose dual therapy; rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days; Other Names: rabeprazole 20 mg qid; amoxicillin 750 mg qid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants in Which H. Pylori Was Eradicated	To assess eradication efficacy with urea breath test	sixth week after the end of anti- H. pylori therapy

Collaborators and Investigators

• Sponsor: Kaohsiung Veterans General Hospital.
• Investigators: Study Chair: Ping-I Hsu, Bachelor, Kaohsiung Veterans General Hospital.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: December 16, 2018
• First Submitted That Met QC Criteria: December 16, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Eradication rate
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Antacids; Metronidazole; Rabeprazole; Amoxicillin; Clarithromycin; Bismuth; Tetracycline
• Other Study ID Numbers: VGHKS18-CT4-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No