Levofloxacin-based concomitant versus sequential therapy for Helicobacter pylori eradication in treatment-naïve Syrian patients: a randomized trial showing no superiority of sequential therapy

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Abstract

BACKGROUND: Helicobacter pylori (H. pylori) infection remains highly prevalent worldwide, including the Eastern Mediterranean region. In Syria, standard triple therapy effectiveness has declined due to increasing antibiotic resistance, misuse, and healthcare limitations. As susceptibility-guided therapy and recommended regimens may be unavailable, empirical levofloxacin-based therapies remain used. This randomized trial compared two levofloxacin-based regimens under local conditions, as sequential therapy has not been evaluated previously in Syrian patients. METHODS: This single-center, prospective, open-label, randomized superiority trial included 150 treatment-naïve adults with histologically confirmed H. pylori infection. Participants were assigned equally to receive either a 14-day levofloxacin-based concomitant regimen or a 14-day levofloxacin-based sequential regimen. The primary outcome was eradication success, confirmed by negative stool antigen testing 6 weeks after therapy and analyzed using intention-to-treat analysis. Treatment-related adverse events were recorded. RESULTS: Intention-to-treat eradication rates were 84%(63/75) with concomitant therapy and 81.3%(61/75) with sequential therapy. The risk difference was 2.7% points (95%CI:-9.4 to 14.8), with no significant difference between groups (p = 0.83;OR = 1.20(95% CI:0.516-2.81). Baseline characteristics were comparable. Both regimens were generally well tolerated. Nausea was the most frequent adverse event, followed by anorexia, headache, bitter taste, and skin rash, with no significant difference in adverse event frequency. CONCLUSION: Levofloxacin-based sequential therapy was not superior to concomitant therapy for eradication in treatment-naïve Syrian patients. The lack of a statistically significant difference does not establish equivalence or non-inferiority. Both regimens showed moderate effectiveness. When levofloxacin-based therapy is required due to limited alternatives, the simpler concomitant regimen may offer practical advantages. These findings should be interpreted considering local resistance patterns and healthcare limitations, with further multi-center studies incorporating susceptibility testing needed. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT06065267), prospectively registered on October 3, 2023.

Abstract as published, via PubMed.