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Efficacy of Vonoprazan and High-Dose Amoxicillin Dual Therapy as a Salvage Regimen for Triple-Resistant Helicobacter pylori Infection: A Clinical Analysis

Efficacy of Vonoprazan and High-Dose Amoxicillin Dual Therapy as a Salvage Regimen for Triple-Resistant Helicobacter pylori Infection: A Clinical Analysis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108827
Enrollment
Unknown
Registered
2025-09-08
Start date
2025-09-08
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Helicobacter pylori infection

Interventions

Vonoprazan and high-dose amoxicillin dual therapy group:None
Personalized bismuth-based quadruple therapy group:None

Sponsors

Nanjing Medical University First Affiliated Hospital (Jiangsu Provincial People's Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age between 18 and 65 years, inclusive, of either gender. 2.Confirmed Helicobacter pylori infection, as determined by a positive C13-urea breath test (UBT) performed at our outpatient clinic. 3.History of at least one treatment failure with a standard 14-day quadruple therapy for H. pylori eradication. 4.Confirmed resistance to metronidazole, clarithromycin, and levofloxacin, based on an antibiotic susceptibility test (AST) performed on gastric biopsy samples obtained via gastroscopy. 5.Patients who received a salvage/rescue therapy regimen for refractory H. pylori at the Gastroenterology outpatient clinic of our hospital.

Exclusion criteria

Exclusion criteria: 1.Previous use of furazolidone or tetracycline in any prior H. pylori eradication regimen. 2.Negative culture result from the antibiotic susceptibility test, or confirmed resistance to amoxicillin, furazolidone, or tetracycline. 3.Presence of acute upper gastrointestinal bleeding, peptic ulcer, or early/advanced upper gastrointestinal malignancy, as identified by gastroscopy. 4.Patients who are pregnant or lactating. 5.Patients with severe, uncontrolled primary diseases of major organ systems, including but not limited to hepatic, renal, cardiac, cerebral, pulmonary, endocrine, or hematopoietic systems.

Design outcomes

Primary

MeasureTime frame
The eradication rate of Helicobacter pylori;

Countries

China

Contacts

Public ContactFeng Ye

Nanjing Medical University First Affiliated Hospital (Jiangsu Provincial People's Hospital)

sdavid1912@stu.njmu.edu.cn+86 25 6830 7087

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026