Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori,Susceptibility testing,empirical,third-line treatment
Brief summary
Aim: Therefore, we aimed to 1. compare the efficacy of susceptibility testing guided therapy vs. empirical therapy in the third-line eradication for refractory H. pylori infection 2. assess the long-term impact of eradication therapy on the antibiotic resistance and microbiota of the gut flora and the metabolic factors. Methods: This will be a multi-center, open labeled trial Patients: 360 patients with failure to H. pylori eradication for at least two times will be enrolled Determination of antibiotic resistance of H. pylori: Agar dilution test will be used to determine the minimum inhibitory concentrations of levofloxacin, tetracycline, rifabutin, and clarithromycin to guide the selection of antibiotics. Treatment regimens and assignment: Eligible patients will be randomized to receive either one of the treatments (A) Susceptibility testing guided therapy or (B) Empirical therapy Outcome Measurement: Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) analyses. Secondary End Point: 1. Eradication rate according to per protocol analysis (PP analysis); 2. Frequency of adverse effects.
Interventions
DRUGET
Empirical therapy Based on drug history: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin triple/quadruple therapy or concomitant therapy
DRUGSGT
Susceptibility testing guided therapy Based on susceptibility test: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin triple/quadruple therapy or concomitant therapy
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adult (equal or greater than 20 years old) patients who failed from at least two eradication therapies for H. pylori infection will be enrolled.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome is the eradication rate in the third treatment according to intention-to treat (ITT) analysis. | 6 weeks | Eradication rate will be determined by urea breath test at least 6 weeks after completion of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects | 2 weeks | A standard interview and questionaire will be used to assess the adverse effects. |
Countries
Taiwan
Contacts
Primary ContactMei-Jyh Chen
Backup ContactYu-Chun Huang
Outcome results
None listed