Vonoprazan High-Dose Dual VS Levofloxacin Concomitant

Overview

This is a randomized controlled trial comparing the efficacy and safety of two vonoprazan-based regimens: high-dose dual therapy (vonoprazan plus a single antibiotic) versus triple therapy (vonoprazan plus two antibiotics) for the treatment of H. pylori infection). Participants will be randomly assigned to receive either regimen for 14 days. The primary outcome is eradication rate , and secondary outcomes include adverse events and treatment adherence.

Study Design: This is a prospective, parallel-group, randomized controlled trial. Setting: multi-center conducted at Damascus hospital and Iben Al-Nfees Hospital Participants: Adult patients aged \[18-70\] years with confirmed \[condition, e.g., H. pylori infection by urea breath test or histology\]. Exclusion criteria include prior \[vonoprazan use / antibiotic allergy / pregnancy / significant comorbidity\]. Interventions: Group A (High-Dose Dual Therapy): Vonoprazan \[20 mg BID\] + \[amoxicillin, 1000 mg three times for 14 days. Group B :levofloxacin concomitant: levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for 14 days. Outcomes: Primary: \[Eradication rate / healing rate\] assessed at \[4-8 weeks post-treatment\]. Secondary: Incidence of adverse events (mild, moderate, severe), treatment adherence (pill count or diary), and \[other outcomes like symptom improvement or cost-effectiveness\]. Sample Size: \[N\] participants per group to achieve \[80-90%\] power with alpha = 0.05. Statistical Analysis: Intention-to-treat and per-protocol analyses. Categorical variables compared using chi-square or Fisher's exact test; continuous variables using t-test or Mann-Whitney U test. A p-value \< 0.05 is considered statistically significant.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes