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Non-invasive Test-guided Tailored Therapy Versus Empiric Treatment for Helicobacter Pylori Infection.

NCT04107194 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 362

Last updated 2021-01-12

No results posted yet for this study

Summary

The aim of our study will be to assess in an open-label, multicenter, randomized controlled trial whether a tailored therapy guided by a non-invasive antibiotic susceptibility test on stool samples achieves higher Helicobacter eradication rates than an empiric antibiotic regimen. For this purpose, consecutive patients with dyspeptic symptoms, diagnosis of Helicobacter pylori infection and naïve to eradicating treatments will be allocated to either of the two intervention arms.

Conditions

  • Helicobacter Pylori Infection
  • Antibiotic Resistant Infection
  • Antibiotic Resistant Strain

Interventions

DRUG

Pantoprazole 40mg

Proton pump inhibitor

DRUG

Amoxicillin 1000 MG

Antibiotic

DRUG

Clarithromycin 500mg

Antibiotic

DRUG

Metronidazole

Antibiotic

DRUG

Tetracycline 125 MG

Antibiotic

DRUG

Bismuth Subcitrate

Antibiotic adjuvant

DRUG

Rifabutin 150 MG

Antibiotic

DRUG

Levofloxacin 500mg

Antibiotic

Sponsors & Collaborators

  • University of Bari

    lead OTHER

Principal Investigators

  • Mariabeatrice Principi, Prof. · University of Bari

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-01-14
Primary Completion
2021-02-14
Completion
2022-04-14

Countries

  • Italy

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 NCT04107194 on ClinicalTrials.gov