Genotypic Resistance Guided Therapy for Refractory H. Pylori Infection

Summary

The inviestigators aimed to compare the efficacy of genotypic resistance guided versus susceptibility testing guided therapy in the third line treatment for refractory H. pylori infection.

Hypothesis:The investigators hypothesized that genotypic resistance guided sequential therapy is non-inferior to empiric therapy in the third line treatment for refractory H. pylori infection.

Methods: This multicenter, open label, parallel group, randomized trial will be conducted since 2017.07.20. Adult (≥20 years old) patients who failed from at least two eradication therapies for H. pylori infection will be enrolled. Genotypic and phenotypic resistances will be determined in patients who failed from at least two eradication therapies by polymerase-chain-reaction with direct sequencing and E-test and agar dilution test, respectively. Eligible patients will be randomized into either one of the treatment groups (A) genotypic resistance guided therapy; or (B) susceptibility testing guided therapy.

Outcome Measurement The primary outcome is the eradication rate in the third line treatment (genotypic versus susceptibility testing guided therapy) according to intention-to-treat (ITT) analysis.

Conditions

• H Pylori Infection

Interventions

DRUG

Esomeprazole 40mg

Nexium (esomeprazole), 40mg, bid, for 14 days

DRUG

Amoxicillin

amoxicillin, 1000mg, bid, for 7 days (day 1-day 7)

DRUG

metronidazole

metronidazole, 500mg, bid, for 7 days (day 8-14)

DRUG

Levofloxacin 500mg

levofloxacin 250mg, bid, for 7 days (day 8-14)

DRUG

Clarithromycin ER

clarithromycin 500mg, bid, for 7 days (day 8-14)

DRUG

Esomeprazole 40mg

Nexium (esomeprazole), 40mg, bid, for 10 days

DRUG

Dibismuth trioxide

Dibismuth trioxide，KCB F.C. TABLETS，300mg，qid, for 10 days

DRUG

metronidazole

metronidazole, 500mg, tid, for 10 days (day 1-10)

DRUG

tetracycline

tetracycline 500mg, qid, for 10 days

Sponsors & Collaborators

• National Taiwan University Hospital

  lead OTHER

Principal Investigators

• Jyh-Ming Liou, MD, PhD · National Taiwan University Hospital (recruiting)

• Yen-Nien Chen, MD · National Taiwan University Hospital Hsin-Chu Branch

• Yu Jen Fang, MD · National Taiwan University Hospital, Yun-Lin Branch

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-12-15

Primary Completion

2021-09-01

Completion

2021-12-31

Countries

• Taiwan