Helicobacter Pylori Infection
Conditions
Keywords
H. pylori, genotypic resistance, tailored therapy, concomitant therapy
Brief summary
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.
Detailed description
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.
Interventions
DRUGEsomeprazole 40mg
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
Use in a drug combination for H. pylori eradication
Use in a drug combination for H. pylori eradication
DRUGRifabutin 150 MG
Use in a drug combination for H. pylori eradication
Sponsors
Konstantopoulio-Patission General Hospital of Nea Ionia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Consecutive outpatients aged ≥18 years with documented H. pylori infection. Mental and legal ability to provide written informed consent.
Exclusion criteria
* previous history of H. pylori eradication therapy * history of allergies to the medications used * previous esophageal or gastric surgery * serious systemic disease * pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of H. pylori eradication | At least 6 weeks after treatment completion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse effects | At least 6 weeks after treatment completion | 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). |
| Compliance rates | At least 6 weeks after treatment completion | 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. |
Countries
Greece
Outcome results
None listed