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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
esomeprazole (20 mg, twice daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days
esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days
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
Liaocheng people's hospital
Liaocheng, Shandong, China
RECRUITINGthe first-line H. pylori eradication rate
the proportion of participants with successful H. pylori eradication, as determined by 13C-Urea breath test(UBT), at least 4 weeks after the end of the first-line treatment period between Susceptibility-guided therapy(SGT) and empirical therapy(ET) group.
Time frame: 4-8 weeks after the end of treatment.
the rescue H. pylori eradication rate
The second line eradication rate between SGT and ET group.
Time frame: 4-8 weeks after the second treatment
the overall H.pylori eradication rate
the total H.pylori eradication rate (first-line and second-line)between SGT and ET group.
Time frame: 4-8 weeks after the second treatment
high-dose dual therapy eradication rate
compare H. pylori eradication rate between clarithromycin resistance group and empirical BQT failure group.
Time frame: 4-8 weeks after the second treatment
Adverse events and compliance
3 days after the completion of therapy according to a data collection form
Time frame: 3 days after the end of treatment.
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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
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
esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days