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Antimicrobial Susceptibility Testing Guided Therapy Versus Empirical Therapy for the First-line Helicobacter Pylori Eradication.

NCT03571230 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2018-06-27

No results posted yet for this study

Summary

The purpose of this study is to assess efficacy of 10-day antimicrobial susceptibility test guided triple therapy for the first-line treatment of Helicobacter pylori infection, then comparing it with 14-day empirical tailored therapy to tell which one has a better performance in both efficacy and safety.

Conditions

  • Helicobacter Pylori Infection
  • Antimicrobial Susceptibility Testing

Interventions

DRUG

two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline)

Patients will receive a 10-day triple therapy for the H.pylori eradication. The regimen contains one PPI and two sensitive antibiotics determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated.

DRUG

two antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone)

Patients will receive a 14-day bismuth-based quadruple therapy for the H.pylori eradication. The regimen contains one PPI, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient has taken clarithromycin, roxithromycin and azithromycin for less than 2 weeks before, he will be treated with amoxicillin and clarithromycin. Otherwise, he will be treated with amoxicillin and furazolidone.

DRUG

one proton pump inhibitor(PPI)

All the patients need this drug.

DRUG

Colloidal Bismuth Pectin

All the patients treated with 14-day bismuth-based quadruple therapy need this drug.

DRUG

two antibiotics for failed eradication(tetracyclin,furazolidone)

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 one PPI, Colloidal Bismuth Pectin, tetracycline and furazolidone.

Sponsors & Collaborators

  • Shandong University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2019-12-30
Completion
2020-01-30

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 NCT03571230 on ClinicalTrials.gov