This study aims to evaluate the efficacy and safety of Keverprazan Hydrochloride combined with Amoxicillin in dual therapy compared to susceptibility-guided quadruple therapy in the treatment of Helicobacter pylori (H. pylori) infections requiring rescue therapy. H. pylori is a common infectious disease associated with peptic ulcers, gastric cancer, and mucosa-associated lymphoid tissue lymphoma. However, the increasing resistance of H. pylori to antibiotics has reduced the eradication rates of standard therapies. Potassium-competitive acid blockers (P-CABs), such as Keverprazan Hydrochloride, provide faster and more sustained gastric acid suppression compared to traditional proton pump inhibitors (PPIs), making them a promising option for H. pylori treatment. This multicenter, randomized controlled trial will provide critical evidence comparing the effectiveness of Keverprazan-based dual therapy to susceptibility-guided quadruple therapy, aiming to establish optimized rescue therapy guidelines for H. pylori eradication.
Helicobacter pylori (H. pylori) is a globally prevalent chronic infectious disease with an infection rate exceeding 50%. As a Gram-negative bacterium, H. pylori survives in the acidic gastric environment and is a major cause of peptic ulcers, gastric mucosa-associated lymphoid tissue lymphoma, and gastric cancer. Eradication of H. pylori can prevent the recurrence of peptic ulcers and reduce the risk of developing gastric cancer. However, increasing antibiotic resistance has significantly decreased the eradication rate of standard triple therapy to below 80%, posing a substantial challenge to effective H. pylori management. This study focuses on evaluating a novel potassium-competitive acid blocker (P-CAB), Keverprazan Hydrochloride, in combination with Amoxicillin as dual therapy for H. pylori rescue treatment. P-CABs, including Keverprazan, offer rapid and sustained gastric acid suppression independent of CYP2C19 polymorphism, overcoming limitations of traditional proton pump inhibitors (PPIs). Recent studies have demonstrated the efficacy of P-CABs in first-line H. pylori treatment with high eradication rates and fewer side effects. However, evidence for their use in rescue therapy is currently lacking. This multicenter, randomized controlled trial aims to compare the efficacy and safety of Keverprazan Hydrochloride-Amoxicillin dual therapy with susceptibility-guided quadruple therapy in patients requiring rescue treatment. The trial will involve patients with confirmed H. pylori infection who failed previous treatment regimens. The study's primary outcome is the eradication rate, and secondary outcomes include the incidence of adverse events and patient compliance. This research is expected to provide critical evidence for the clinical application of Keverprazan Hydrochloride in H. pylori rescue therapy, potentially establishing it as an effective and patient-friendly treatment option.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
316
Keverprazan Hydrochloride, a potassium-competitive acid blocker (P-CAB), is administered at a dose of 20 mg twice daily in combination with Amoxicillin 0.75 g four times daily for 14 days. This dual therapy is designed to provide rapid and sustained gastric acid suppression and evaluate its efficacy in eradicating Helicobacter pylori.
Participants in this arm will receive quadruple therapy tailored to individual H. pylori resistance profiles, including a proton pump inhibitor (Esomeprazole 20 mg), Bismuth Potassium Citrate 220 mg, and two antibiotics selected based on susceptibility testing (e.g., Amoxicillin, Clarithromycin, Metronidazole, Levofloxacin, or Furazolidone). The regimen is administered for 14 days to optimize eradication outcomes.
Proportion of Participants with Successful Eradication of Helicobacter pylori
The proportion of participants who achieve successful eradication of Helicobacter pylori. Eradication is defined as a negative result on the 13C-Urea Breath Test (13C-UBT) conducted at least 4 weeks after the last dose of the study medication. The eradication rate will be calculated as: Eradication Rate=(Number of Participants with Successful Eradication/ Total number of participants)\*100% This outcome will compare the efficacy of Keverprazan Hydrochloride + Amoxicillin dual therapy to susceptibility-guided quadruple therapy in the rescue treatment of H. pylori infection.
Time frame: At least 4 weeks after the last dose of study medication
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