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Susceptibility-guided Bismuth Quadruple Therapy for Multi-resistant H. pylori
NCT06687499Phase 4
Key facts
- Status
- Completed
- Start
- Aug 2022
- Primary completion
- Dec 2023
- Countries
- 1
- Sponsor
- National Cheng Kung University Hospital
- Modality
- DNA Intercalators/Alkylators
- Drugs
- bismuth subcitrate
- Conditions
- Helicobacter pylori infection
01
Overview
Phase 4, open-label, single-arm trial of bismuth subcitrate in Helicobacter pylori infection, sponsored by National Cheng Kung University Hospital. Primary endpoint: The eradication rate of H. pylori. Started Aug 2022; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Bismuth-based susceptibility-guided treatment
Participants receive one of four regimens (PBAT, PBAM, PBMT, PBMR) based on susceptibility test results.
03
Who it enrols
Adults with H. pylori infection who have failed at least one eradication course or are treatment-naive with multi-drug resistant strains (>=3 antibiotics). Excludes patients with dual or mono-resistance, severe comorbidities, or CKD < 60 mL/min/1.73m^2.
04
Endpoints
Primary
The eradication rate of H. pylori
Secondary
Adverse effects
Adherence to medications
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