Overview

Comparison of the Levofloxacin Sequential Therapy and Quadruple Therapy in Second Line Treatment for HP

Status:
Unknown status
Trial end date:
2019-04-01
Target enrollment:
Participant gender:
Summary
Objectives: Eradication of H. pylori infection could reduce the occurence or recurrence of gastric cancer and peptic ulcer diseases. However, it was estimated that 15-20% of patients would fail from first line standard eradication therapy and need second line rescue therapy. About 15-30% of patient would fail from second line therapy. Bismuth quadruple therapy and triple therapy containing levofloxacin are currently the recommended rescue therapies in the second line and third line treatment. Recently, our pilot study showed that modified sequential therapy containing levofloxacin achieved high eradication rate (95%) in the second line therapy. The regimen includes a PPI plus amoxicillin for 5-7 days, followed by a PPI plus levofloxacin and metronidazole for another 5-7 days. However, whether this modified sequential therapy containing levofloxacin is more effective than bismuth quadruple therapy in the second line and third line treatment remains unknown. Besides, the impact of these regimens on the antibiotic resistance , microbiota of gut flora, and metabolic factors remains unknown. Aims: Therefore, the investigators aimed to 1. compare the eradication rates and long term re-infection rates of sequential therapy containing levofloxacin for 14 days versus bismuth quadruple therapy for 10 days in the second line and third line treatment 2. assess the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of these regimens 3. assess the impact of these eradication regimens on the antibiotic resistance and microbiota of the gut flora 4. assess the impact of eradication therapy on the metabolic factors
Phase:
Phase 3
Details
Lead Sponsor:
National Taiwan University Hospital
Treatments:
Bismuth
Esomeprazole
Levofloxacin
Metronidazole
Ofloxacin