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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Bismuth; Esomeprazole; Levofloxacin; Metronidazole; Ofloxacin

Criteria

Inclusion Criteria:

1. H. pylori infected patients who failed from first line standard triple therapy with clarithromycin, amoxicillin, and a proton pump inhibitor were eligible in this study

Exclusion Criteria:

1. children and teenagers aged less than 20 years,

2. history of gastrectomy,

3. gastric malignancy, including adenocarcinoma and lymphoma,

4. previous allergic reaction to antibiotics (bismuth, metronidazole, levofloxacin, tetracycline) and PPI (esomeprazole),

5. contraindication to treatment drugs,

6. pregnant or lactating women,

7. severe concurrent disease, or

8. Unwilling to accept random assignment of subjects