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Efficacy of Vonoprazan, Sitafloxacin and Amoxicillin Regimen for Treatment of Refractory Helicobacter pylori infection

Efficacy of Vonoprazan, Sitafloxacin and Amoxicillin Regimen for Treatment of Refractory Helicobacter pylori infection

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20211203002
Enrollment
20
Registered
2021-12-03
Start date
2022-01-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Vonoprazan 20 mg twice daily (40mg/day) Sitafloxacin 100 mg twice daily (200mg/day) Amoxycillin 1000 mg twice daily (2000 mg/day) Duration : 7 days
Experimental Drug
VAS rigimens

Sponsors

Routine to Research Unit, Siriraj Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patient with refractory H.pylori defined as failed to at least 2 H.pylori eradication regimens

Exclusion criteria

Exclusion criteria: - Patient with history to sitafloxacin, amoxycillin or vonoprazan allergy - Pregnancy - Patient with immunodeficiency, decompensated cirrhosis and end stage renal disease.

Design outcomes

Primary

MeasureTime frame
Efficacy (eradication rate of VAS regimen) 4 weeks after intervention Percentage of successful eradication

Secondary

MeasureTime frame
Characteristic of Refractory H.pyloi infection patients at the begin of study Age, sex, antibiotic susceptibility of H.pylori, CYP2C19 polymorphism

Countries

Thailand

Contacts

Public ContactTanawat Geeratragool

Division of gastroenterology and hepatology, Department of internal medicine, Faculty of medicine Siriraj hospital

tanawat_gee@hotmail.co.th66823430096

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026