Efficacy of Vonoprazan, Sitafloxacin and Amoxicillin Regimen for Treatment of Refractory Helicobacter pylori infectio
Phase 3
- Conditions
- Prevalence of helicobacter pylori is 17-55%. Ten to twenty percents of H.pylori infection were failed to treatment with first line regimen. Refractory H.pylori infection defined as H.pylori infection which failed to treatment with at least 2 regimens. There was not standard regimen for H.pylori infection.Refractory Helicobacter pylori, Helicobacter pylori, Resistant Helicobacter pylori
- Registration Number
- TCTR20211203002
- Lead Sponsor
- Routine to Research Unit, Siriraj Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Patient with refractory H.pylori defined as failed to at least 2 H.pylori eradication regimens
Exclusion Criteria
- Patient with history to sitafloxacin, amoxycillin or vonoprazan allergy
- Pregnancy
- Patient with immunodeficiency, decompensated cirrhosis and end stage renal disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy (eradication rate of VAS regimen) 4 weeks after intervention Percentage of successful eradication
- Secondary Outcome Measures
Name Time Method Characteristic of Refractory H.pyloi infection patients at the begin of study Age, sex, antibiotic susceptibility of H.pylori, CYP2C19 polymorphism