Vonoprazan-amoxicillin dual, rifabutin-based triple, and bismuth quadruple therapies for Helicobacter pylori rescue treatment: a multicentre, open-label, non-inferiority randomised trial
Abstract
Background: Whether vonoprazan-amoxicillin dual therapy (VA) or rifabutin-based triple study (VRA) can replace bismuth quadruple therapy (BQT) for Helicobacter pylori rescue treatment remains unclear. We aimed to evaluate the efficacy and safety of 10-day VA and VRA regimens, compared with BQT, for rescue therapy.
Methods: We conducted an open-label, non-inferiority randomised controlled trial at three hospitals in China. Refractory H. pylori-infected patients with at least two previous treatment failures were randomly assigned (1:1:1; block sizes six) to 10 days vonoprazan-containing (20 mg twice daily) regimens of VA (amoxicillin 1000 mg three times daily); VRA (amoxicillin 1000 mg three times daily, and rifabutin 150 mg twice daily); or BQT (bismuth 110 mg, tetracycline 500 mg, and metronidazole 400 mg, all four times daily). The primary endpoint was H. pylori eradication rate evaluated by 13C-urea breath test. Adverse events were assessed in all patients. Non-inferiority margin was -10%. This trial is registered at ClinicalTrials.gov (NCT05874544).
Findings: Between May 16, 2023, and Jan 31, 2025, 360 subjects (110 [31%] male and 250 [69%] female; mean age 48.4 years [SD 12.1]) were randomly assigned to VA, VRA or BQT (n = 120 per group). Intention-to-treat eradication rates were 75.8% (91/120; 95% CI 67.0-83.0) with VA, 90.0% (108/120; 95% CI 82.8-94.5) with VRA, and 90.8% (109/120; 95% CI 83.8-95.1) with BQT. Non-inferiority of VA to BQT was not established (difference…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 120 participants or records.
Read the paper
Related studies
- Ferulic acid regulates the AKT/GSK-3β/CRMP-2 signaling pathway in a middle cerebral artery occlusion animal model
- Novel Pharmacokinetic/Pharmacodynamic Parameters Quantify the Exposure–Effect Relationship of Levofloxacin against Fluoroquinolone-Resistant Escherichia coli
- Photochemical behavior of levofloxacin
- Correlation Between Dissolution Profiles of Salt-Form Drugs in Biorelevant Bicarbonate Buffer and Oral Drug Absorption: Importance of Dose/ Fluid Volume Ratio
- Evaluation of the synergistic potential and mechanisms of action for de novo designed cationic antimicrobial peptides
- Synthesis of [11C]levofloxacin
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.