Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection

Liaocheng People's Hospital

Status: Enrolling

Conditions: Helicobacter Pylori Infection

Treatments: Drug: empirical therapy group rescue treatment; Drug: clarithromycin-sensitive(first-line); Drug: clarithromycin-resistant(first-line); Drug: levofloxacin-sensitive(rescue treatment); Drug: levofloxacin-resistant(rescue treatment); Drug: empirical therapy group first-line

Study type: Interventional

Funder types: Other

Identifiers

NCT05549115

CS-HP001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 6 patient groups

clarithromycin-sensitive(first-line)

Experimental group

Description:

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

Treatment:

Drug: clarithromycin-sensitive(first-line)

clarithromycin-resistant(first-line)

Experimental group

Description:

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.

Treatment:

Drug: clarithromycin-resistant(first-line)

empirical therapy group first-line

Active Comparator group

Description:

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.

Treatment:

Drug: empirical therapy group first-line

levofloxacin-sensitive(rescue treatment)

Experimental group

Description:

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.

Treatment:

Drug: levofloxacin-sensitive(rescue treatment)

levofloxacin-resistant(rescue treatment)

Experimental group

Description:

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.

Treatment:

Drug: levofloxacin-resistant(rescue treatment)

empirical therapy group rescue treatment

Active Comparator group

Description:

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.

Treatment:

Drug: empirical therapy group rescue treatment