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Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection

NCT05549115 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2023-12-12

No results posted yet for this study

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.

Conditions

  • Helicobacter Pylori Infection

Interventions

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

Sponsors & Collaborators

  • Liaocheng People's Hospital

    lead OTHER

Principal Investigators

  • Jing run Zhao, Dr · Liaocheng People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-20
Primary Completion
2024-02-29
Completion
2024-02-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05549115 on ClinicalTrials.gov