1242

COMPARISON OF EMPIRICAL THERAPY VERSUS SUSCEPTIBILITY TESTING-GUIDED THERAPY FOR REFRACTORY HELICOBACTER PYLORI INFECTION: A MULTICENTER, OPEN-LABEL, RANDOMIZED CONTROLLED, NON-INFERIORY TRIAL

Date
May 21, 2024

Background and Aims: There is limited evidence to support whether optimized empirical therapy can be an alternative to susceptibility testing guided therapy for patients with refractory Helicobacter pylori (H. pylori) infection defined as failure after two or more eradication attempts. We aimed to assess whether optimized empirical therapy by early use of rifabutin, potent acid inhibitor, and quadruple therapy, is non-inferior to susceptibility testing guided therapy for refractory H. pylori infection.
Methods: We conducted a multi-center, open label, randomized controlled trials in Taiwan. Eligible patients were allocated in a 1:1 ratio to receive either empirical guided therapy or susceptibility testing guided therapy. The minimum inhibition concentrations (MICs) of levofloxacin, metronidazole, tetracycline, rifabutin, and clarithromycin resistance were determined by agar dilution test. Study participants received levofloxacin-based quadruple therapy or bismuth quadruple therapy or rifabutin-based therapy or clarithromycin-based concomitant therapy according to the previous medication history or susceptibility testing (Figure 1). The 13C-urea breath test was used to determine the status of H. pylori at least 6 weeks after completing eradication therapy. Eradication rates were analyzed according to intent-to-treat (ITT) andper protocol (PP) analyses. The pre-specified margins for non-inferiority analyses were pre-specified as 9%.
Results: Among 198 patients with refractory H. pylori infection were randomly assigned and underwent post-eradication evaluation, the eradication rates in the empirical guided therapy group and the susceptibility guided therapy group were 83.8% (95% CI: 76.6%-91.1%) versus 83.8% (95% CI: 76.6%-91.1%) in the ITT analysis (p-value=1.000), and were 83.7% (95% CI: 76.4%-91.0%) versus 85.6% (95% CI: 78.6%-92.6%) in the PP analysis (p-value=0.714), respectively (Figure 2). The difference of eradication rate between the MTGT and STGT groups was 0% (95% CI: -8.7%-8.7%, non-inferiority p-value=0.045) by ITT analysis, and was -1.9% (95% CI: -10.5%-6.7%, non-inferiority p-value=0.087) by PP analysis.
Conclusions: Optimized empirical therapy was not inferior to susceptibility testing guided therapy for refractory H. pylori infection.

Tracks

Related Products

Thumbnail for GENOTYPIC RESISTANCE GUIDED THERAPY VERSUS SUSCEPTIBILITY TESTING GUIDED THERAPY IN THE FIRST-LINE AND THIRD-LINE TREATMENT OF HELICOBACTER PYLORI INFECTION-TWO MULTICENTER RANDOMIZED CONTROLLED TRIALS
GENOTYPIC RESISTANCE GUIDED THERAPY VERSUS SUSCEPTIBILITY TESTING GUIDED THERAPY IN THE FIRST-LINE AND THIRD-LINE TREATMENT OF HELICOBACTER PYLORI INFECTION-TWO MULTICENTER RANDOMIZED CONTROLLED TRIALS
INTRODUCTION. Our previous study reported a significant increase in metachronous recurrence of early gastric cancer after endoscopic submucosal dissection due to CD44v9-positive cancer stem-like cells in _H. pylori_-infected stomach tissue (_BR. J. CANCER_ 109:379, 2013)…
Thumbnail for TAIWAN CANCER MOONSHOT PROJECT INTERIM REPORT: DECIPHERING DIVERGENT PATHS THROUGH IN-DEPTH COMPARATIVE MULTIOMIC ANALYSIS OF H. PYLORI-ASSOCIATED AND INDEPENDENT GASTRIC CANCER SIGNATURES
TAIWAN CANCER MOONSHOT PROJECT INTERIM REPORT: DECIPHERING DIVERGENT PATHS THROUGH IN-DEPTH COMPARATIVE MULTIOMIC ANALYSIS OF H. PYLORI-ASSOCIATED AND INDEPENDENT GASTRIC CANCER SIGNATURES
Gastric cancer, ranking as the fifth most prevalent cancer globally, involves complex etiologies, including but not limited to H. pylori infection. This interim report is part of a comprehensive multi-omic analysis from the Taiwan Cancer Moonshot Project on Gastric Cancer…
Thumbnail for INCREMENTAL EFFECTIVENESS OF REDUCING COLORECTAL CANCER INCIDENCE WITH FECAL IMMUNOCHEMICAL TEST SCREENING FROM AGE 40 TO 49 YEARS: A POPULATION STUDY IN TAIWAN
INCREMENTAL EFFECTIVENESS OF REDUCING COLORECTAL CANCER INCIDENCE WITH FECAL IMMUNOCHEMICAL TEST SCREENING FROM AGE 40 TO 49 YEARS: A POPULATION STUDY IN TAIWAN
INTRODUCTION: The ultimate goal of colorectal cancer (CRC) screening is to prevent CRC by detecting advanced adenomas that potentially progress to CRC…
Thumbnail for TEMPORAL CHANGE OF T1N1 STAGE III COLORECTAL CANCER IN THE CONTEXT OF FECAL IMMUNOCHEMICAL TEST-BASED COLORECTAL CANCER SCREENING PROGRAM IMPLEMENTATION AND ITS POTENTIAL IMPACT ON SCREENING EFFECTIVENESS
TEMPORAL CHANGE OF T1N1 STAGE III COLORECTAL CANCER IN THE CONTEXT OF FECAL IMMUNOCHEMICAL TEST-BASED COLORECTAL CANCER SCREENING PROGRAM IMPLEMENTATION AND ITS POTENTIAL IMPACT ON SCREENING EFFECTIVENESS
BACKGROUND: Traditionally, stage shifting has served as a surrogate indicator of effectiveness in a population-based colorectal cancer screening program. However, the specific components within each stage are rarely explored…