drugset / Trial / NCT06351891

Efficacy and Safety of Bismuth Quadruple Therapy Containing Cefuroxime and Tetracycline as First-line Therapy for Eradicating Helicobacter Pylori in Patients Allergic to Penicillin

NCT06351891 ↗

Phase 4 Unknown 248 enrolled Qilu Hospital of Shandong University
RandomizedParallel-groupOpen-labelTreatment

Summary

The researchers collected untreated H. pylori positive patients from outpatient clinics. Subjects were randomly assigned to receive either 14 days of bismuth quadruple therapy with cefuroxime and tetracycline or 14 days of bismuth quadruple therapy with cefuroxime and levofloxacin for Helicobacter pylori eradication. After 6 weeks of treatment, subjects underwent another 13C urea breath test. Eradication rates, adverse reaction rates and patient compliance were calculated.

Timeline

Start
2024-04
Primary completion
2024-12
Completion
2024-12

Outcome

Met primary endpoint

paper Noninferiority of the Cef-Tet BQT group was demonstrated in all three analyses (p < 0.0001). PMID 40237213 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Levofloxacin Small molecule 500 mg —
Subject Tetracycline Unknown 500 mg —
Background Bismuth Potassium Citrate Unknown 0.6 g —
Background Cefuroxime Small molecule 500 mg —
Background Tegoprazan Other / unclassified 50 mg —