Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Drug: empirical therapy group rescue treatmentDrug: empirical therapy group first-lineDrug: clarithromycin-sensitive(first-line)Drug: levofloxacin-sensitive(rescue treatment)Drug: clarithromycin-resistant(first-line)Drug: levofloxacin-resistant(rescue treatment)
- Registration Number
- NCT05549115
- Lead Sponsor
- Liaocheng People's Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description empirical therapy group rescue treatment empirical therapy group rescue treatment If BQT fails, HDDT-esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily)-will be used as a rescue treatment for 14 days. empirical therapy group first-line empirical therapy group first-line The empirical therapy group will receive Bismuth-containing quadruple therapy(BQT) as first-line treatment, The BQT regime is comprising of 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. clarithromycin-sensitive(first-line) clarithromycin-sensitive(first-line) If H. pylori is sensitive to clarithromycin, we will administer clarithromycin triple therapy-esomeprazole (20 mg, twice daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily)-for 14 days levofloxacin-sensitive(rescue treatment) levofloxacin-sensitive(rescue treatment) If H. pylori was levofloxacin-sensitive, we will use the levofloxacin quadruple regimen as 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. clarithromycin-resistant(first-line) clarithromycin-resistant(first-line) If H. pylori is clarithromycin resistance, we selected the High-dose dual therapy (HDDT) regimen as first-line treatment. HDDT-esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily)-will be used for 14 days. levofloxacin-resistant(rescue treatment) levofloxacin-resistant(rescue treatment) If H. pylori was levofloxacin-resistant, we will use furazolidone quadruple regimen as 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Liaocheng people's hospital
🇨🇳Liaocheng, Shandong, China