This study aims to investigate the efficacy of a 7-day genotypic resistance-guided triple therapy, compared with empirical concomitant therapy, for first-line eradication of H. pylori.
Empiric eradication of H. pylori becomes steadily more challenging because of increasing antibiotic resistance. In high-resistance countries where bismuth and/or tetracycline are unavailable (eg; Greece), non-bismuth quadruple therapies are currently recommended as first-line therapeutic options; however, eradication rates \>95% are infrequently achieved and even \>90% are disputed. Antimicrobial susceptibility-guided therapy is a promising alternative in order to maintain high therapeutic efficacy. However, traditional culture-based susceptibility testing methods have several shortcomings, including they are time-consuming and they do not 100% reflect in vivo eradication. Recent guidelines also recommend the use of molecular testing for evaluation of H. pylori antibiotic susceptibility. Nevertheless, the efficacy of genotypic resistance-guided treatment of H. pylori has been seldom appraised. Therefore, the investigators conducted this prospective randomized controlled trial aiming to investigate the efficacy of a 7-day genotypic resistance-guided triple therapy, compared with empirical concomitant therapy, for first-line eradication of H. pylori.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
304
Use in a drug combination for H. pylori eradication
Use in a drug combination for H. pylori eradication
Use in a drug combination for H. pylori eradication
Konstantopoulio-Patision General Hospital
Athens, Nea Ionia, Greece
RECRUITINGRate of H. pylori eradication
Rate of H. pylori eradication by intention to treat/per protocol in each group at least 6 weeks after treatment completion using the urea breath test.
Time frame: At least 6 weeks after treatment completion
Rate of adverse effects
Adverse events were investigated by means of a structured clinical interview immediately after the completion of therapy. The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities).
Time frame: At least 6 weeks after treatment completion
Compliance rates
Drug compliance was determined by counting unused medication. For this purpose, any tablet that was not consumed was brought back to the clinic for pill count. Poor compliance was defined as taking less than 80% of the total medication prescribed.
Time frame: At least 6 weeks after treatment completion
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Use in a drug combination for H. pylori eradication
Use in a drug combination for H. pylori eradication
Use in a drug combination for H. pylori eradication