Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, Drug Resistance, Microbial, Microbial Sensitivity Tests
Brief 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.
Interventions
DRUGclarithromycin-sensitive(first-line)
esomeprazole (20 mg, twice daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days
DRUGclarithromycin-resistant(first-line)
esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days
DRUGempirical 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
DRUGlevofloxacin-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
DRUGlevofloxacin-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
DRUGempirical therapy group rescue treatment
esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days
Sponsors
Liaocheng People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* H. pylori infection was determined using at least one of the following tests: 13C/14C-urea breath test (UBT), stool H. pylori antigen test, rapid urease test, and histological analysis within 4 weeks. * Patients were naïve to H. pylori treatment.
Exclusion criteria
* Allergy to any drug administered. * Pregnancy and lactation. * Major systemic diseases, such as severe cardiopulmonary or liver dysfunction. * Complicated with active peptic ulcer disease, gastric cancer, or prior gastrectomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the first-line H. pylori eradication rate | 4-8 weeks after the end of treatment. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the rescue H. pylori eradication rate | 4-8 weeks after the second treatment | The second line eradication rate between SGT and ET group. |
| the overall H.pylori eradication rate | 4-8 weeks after the second treatment | the total H.pylori eradication rate (first-line and second-line)between SGT and ET group. |
| high-dose dual therapy eradication rate | 4-8 weeks after the second treatment | compare H. pylori eradication rate between clarithromycin resistance group and empirical BQT failure group. |
| Adverse events and compliance | 3 days after the end of treatment. | 3 days after the completion of therapy according to a data collection form |
Countries
China
Contacts
Primary ContactJing run Zhao, Dr
Outcome results
None listed