MedTrace Logo

Antimicrobial Susceptibility Testing Guided Therapy Versus Empirical Therapy for the Rescue Treatment of Helicobacter Pylori Infection

NCT03565484 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2020-05-12

No results posted yet for this study

Summary

The purpose of this study is to assess efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection, then comparing it with 14-day personal medication history guided therapy to tell which one has a better performance in both efficacy and safety.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

susceptibility guided therapy

Patients will take a gastroscopy and 2 biopsies will be attained from antrum and gastric body for H.pylori culture and antimicrobial susceptibility testing (AST). The susceptibility of amoxicillin, clarithromycin, metronidazole, levofloxacin, furazolidone and tetracycline will be tested.Then patients with positive culture will be treated with a 14-day quadruple therapy for the H.pylori eradication. The regimen contains rabeprazole 20mg bid, colloidal bismuth pectin 200mg bid, and two sensitive antibiotics determined by AST. Dose of two sensitive antibiotics are listed as follows : amoxicillin 1000mg bid, clarithromycin 500mg bid, tinidazole 500mg tid, levofloxacin 500mg qd, furazolidone 100mg bid, tetracycline 500mg qid.

DRUG

personal medication history guided therapy

Patients will be treated with a 14-day emprical tailored quadruple therapy for the H.pylori eradication. The regimen contains rabeprazole 20mg bid， colloidal bismuth pectin 200mg bid and two antibiotics based on personal medication history. If the patient doesn't have levofloxacin history, he will be treated with amoxicillin 1000mg bid plus levofloxacin 500mg bid. Otherwise, he will be treated with amoxicillin 1000mg bid and furazolidone 100mg bid.

DRUG

salvage treatment for failed eradication

If the patients failed with AST guided eradication therapy or empirical therapy, patients will be treated with another 14-day bismuth-based quadruple therapy. The regimen contains rabeprazole 20mg bid, colloidal bismuth pectin 200mg bid, tetracycline 500mg qid and furazolidone 100mg bid.

Sponsors & Collaborators

  • Shandong University

    lead OTHER

Principal Investigators

  • Xiuli Zuo, MD,PhD · Qilu Hospital of Shandong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2020-05-30
Completion
2020-06-30

Countries

  • China

Study Locations

More Related Trials

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 NCT03565484 on ClinicalTrials.gov