Genotypic Resistance Guided Therapy for Refractory H. Pylori Infection
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
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.