NCT05549115

Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection

Susceptibility-Guided Sequential Therapy Versus Empirical Therapy for Helicobacter Pylori Infection: a Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Liaocheng People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this trial is to assess whether a sequential therapy strategy based on molecular antibiotic susceptibility testing (including clarithromycin and fluoroquinolone) for H. pylori infection will improve the eradication rate compared to an empirical therapy.

Detailed description

This trial is designed as a prospective, randomised, open-label, active-controlled and single-centre study. For empirical therapy group(control group), Bismuth quadruple therapy will be an empirical first-line therapy, and high dose dual (proton-pump inhibitor + amoxicillin) treatment will be for rescue therapy if the first-line empirical treat failure. For the susceptibility-guided sequential therapy group, regimens were selected based on H. pylori susceptibility to clarithromycin and levofloxacin. The primary outcome is the first-line eradication rate in both groups, and the overall (including first- and rescue therapies) H. pylori eradication rates in both groups is one of the secondary outcomes. The eradication rates of H. pylori will be analysed by intention-to-treat analysis, modified intention-to-treat analysis and per-protocol analysis.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	clarithromycin-sensitive(first-line)	esomeprazole (20 mg, twice daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days
DRUG	clarithromycin-resistant(first-line)	esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days
DRUG	empirical therapy group first-line	esomeprazole (20 mg, twice daily), colloidal bismuth pectin (150 mg, four times daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days
DRUG	levofloxacin-sensitive(rescue treatment)	esomeprazole (20 mg, twice daily), levofloxacin (500 mg, once daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily) for 14 days
DRUG	levofloxacin-resistant(rescue treatment)	esomeprazole (20 mg, twice daily), furazolidone (100 mg, twice daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily) for 14 days
DRUG	empirical therapy group rescue treatment	esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days

Timeline

• Start date: 2022-09-20
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2022-09-22
• Last updated: 2023-12-12

Locations

1 site across 1 country: China