Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Triple Therapy as Second Line Therapy

National Taiwan University Hospital600 enrolled

Overview

To compare the efficacy and tolerability of levofloxacin-based sequential therapy and triple therapy in the second line therapy for those who fail from one eradication therapy

About 600 patients who failed from first line triple therapy or sequential therapy will be eligible in this multicenter randomized comparative trial. Eligible patients will be randomized to receive either (1) levofloxacin-based sequential therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g for the first 5 days, followed by lansoprazole 30mg, levofloxacin 250mg, and metronidazole 500mg for another 5 days (all given twice daily)〕or (2) levofloxacin-based triple therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)〕. Eradication will be confirmed with 13C-Urea Breath Test 6 weeks after therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

600

Conditions

Eradication Rate for Helicobacter

Interventions

levofloxacin-based sequential therapyDRUG

levofloxacin-based sequential therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g for the first 5 days, followed by lansoprazole 30mg, levofloxacin 250mg, and metronidazole 500mg for another 5 days (all given twice daily)〕

levofloxacin-based triple therapy for 10 daysDRUG

lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * H. pylori infected patients who failed from first line therapy will be eligible in this study Exclusion Criteria: * Patients were excluded from the study if any one of the following criteria was present: * children and teenagers aged less than 20 years, * history of gastrectomy, * gastric malignancy, including adenocarcinoma and lymphoma, * previous allergic reaction to antibiotics (amoxicillin, metronidazole, levofloxacin) and PPI (lansoprazole), * contraindication to treatment drugs, * pregnant or lactating women, or * severe concurrent disease

Locations (10)

National Taiwan University Hospital, Hsinchu Branch

Hsinchu, Taiwan

RECRUITING

E-DA Hospital and I-Shou University

Kaohsiung City, Taiwan

RECRUITING

Kaohsiung Medical University

Outcomes

Primary Outcomes

Eradication rate in the second line therapy

Assessed by UBT

Time frame: 6 weeks

Secondary Outcomes

Incidence of adverse effect

during treatment

Time frame: 2 weeks

Central Contacts

Jyh-Ming Liou, MD

CONTACT

886-972651883 dtmed046@pchome.com.tw

Data from ClinicalTrials.gov

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