Self Efficacy
Conditions
Keywords
genotypic resistance guided therapy
Brief summary
We aimed to compare the efficacy of genotypic resistance guided sequential therapy vs. empiric therapy in the third line therapy. Factors affecting the eradication rates, including the antibiotic resistance, CYP2C19 polymorphism, CagA and VacA status will also be assessed.
Detailed description
The primary aim of this study is to compare the regimens selected using either one of the method (1) genotypic resistance guided versus (2) medication history guided therapy. (rather than to compare the efficacy of any drugs).
Interventions
1. Nexium (esomeprazole), 40mg, bid, 14 days, plus 2. Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus 3. Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs 4. Select either one of the drugs according to medication history Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14
DRUGGenotypic resistance guided therapy
1. Nexium (esomeprazole), 40mg, bid, 14 days, plus 2. Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus 3. Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs 4. Select either one of the drugs according to genotypic resistance results Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14
Sponsors
National Science and Technology Council, Taiwan
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged greater than 20 years who have persistent H. pylori infection after at least two treatments and are willing to receive third line rescue regimens are considered eligible for enrollment.
Exclusion criteria
* Patients will be excluded from the study if any one of the following criteria is present: (1) children and teenagers aged less than 20 years, (2) history of gastrectomy, (3)gastric malignancy, including adenocarcinoma and lymphoma, (4) previous allergic reaction to antibiotics (Amoxicillin, Klaricid, Cravit) and prompt pump inhibitors (esomeprazole), (5)contraindication to treatment drugs, (6) pregnant or lactating women, (7) severe concurrent disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rate after third line rescue therapy | 8 weeks | Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses. (genotypic resistance versus empirical therapy) Urea breath test will be used to determine the eradication status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| eradication rates in subgroup analysis by antibiotic resistance and regimen | 8 weeks | eradication rate in subgroup analysis according to antibiotic resistance and treatment regimen |
Countries
Taiwan
Contacts
Primary ContactJyh-Ming Liou, MD
Outcome results
None listed