Efficacy and Safety of Cefuroxime-Tetracycline-Containing Bismuth Quadruple Therapy for Helicobacter pylori Eradication in Penicillin-Allergic Patients: A Multicenter Randomized Controlled Trial.

BACKGROUND

Penicillin allergy significantly restricts therapeutic options for Helicobacter pylori eradication. This multicenter randomized controlled study was designed to evaluate the efficacy and safety of a novel cefuroxime-tetracycline-containing bismuth quadruple therapy (Cef-Tet BQT) as first-line treatment in this population.

MATERIALS AND

METHODS

Penicillin-allergic treatment-naïve patients with confirmed H. pylori infection (N = 248) were randomized to two 14-day regimens: one received Cef-Tet BQT (Tegoprazan 50 mg twice a day, bismuth potassium citrate 220 mg twice daily, cefuroxime 500 mg twice daily, tetracycline 500 mg three times daily), and the other received cefuroxime-levofloxacin-containing bismuth quadruple therapy (Cef-Lev BQT: cefuroxime 500 mg twice daily, levofloxacin 500 mg once daily). The primary endpoint assessed noninferiority of eradication rates, with secondary endpoints including safety profiles and adherence.

RESULTS

In total, 248 patients underwent randomization. The intention-to-treat (ITT) eradication rates were 90.32% (112/124, 95% confidence interval [CI]: 85.12%-95.52%) and 81.45% (101/124, 95% CI: 74.61%-88.29%) (p = 0.045); the modified intention-to-treat (MITT) eradication rates were 91.80% (112/122, 95% CI: 86.93%-96.67%) and 83.47% (101/121, 95% CI: 76.85%-90.09%) (p = 0.048); and the per-protocol (PP) eradication rates were 92.37% (109/118, 95% CI: 87.58%-97.16%) and 85.34% (99/116, 95% CI: 78.90%-91.78%) (p = 0.087) in the Cef-Tet BQT group and Cef-Lev BQT group, respectively. Noninferiority of the Cef-Tet BQT group was demonstrated in all three analyses (p < 0.0001). The incidence of adverse events (21.77% vs. 24.19%) and compliance (96.77% vs. 95.97%) were comparable between the two groups.

CONCLUSIONS

BQT containing cefuroxime and tetracycline is efficacious and safe for the first-line eradication of H. pylori in penicillin-allergic patients. This regimen provides a viable alternative to circumvent the antimicrobial resistance concerns associated with levofloxacin-based regimens.

TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT06351891.