Levofloxacin-containing Therapies In Second Line Helicobacter Pylori Eradication

Chang Gung Memorial Hospital164 enrolled

Overview

Asia Pacific Consensus states that levofloxacin-based triple therapy as an alternative second-line therapy after Helicobacter pylori (H. pylori) eradication failure when bismuth salts are not available. The investigators compare the efficacies of 10-day levofloxacin-based sequential therapy and 10-day triple therapy in the treatment for patients after failure of standard triple therapy and to determine what clinical and bacterial factors influencing the efficacy of salvage regimens.

In this randomized-controlled trial , the investigator recruited participants with H pylori infection after failure of first line standard triple therapy. Using a computer-generated randomization sequence, the investigators randomly allocated patients to either 10-day levofloxacin-containing sequential (EALM, esomeprazole 40 mg b.d., amoxicillin 1 g b.d.for 5 days and followed by esomeprazole 40 mg b.d., levofloxacin 500 mg qd and metronidazole for 5 days) or 10-day levofloxacin-containing triple therapy (EAL, esomeprazole 40 mg b.d., amoxicillin 1 g b.d., and levofloxacin 500 mg qd) at a 1:1 ratio. The primary outcome was the eradication rate by intention-to-treat and per-protocol analyses.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

164

Conditions

Helicobacter Pylori Infection

Interventions

NexiumDRUG

Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms

AmolinDRUG

Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm

CravitDRUG

Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Consecutive H. pylori-infected participants, at least 18 years of age, with endoscopically proven peptic ulcer diseases or gastritis who failed first-line eradication therapies with standard triple regimens (PPI twice daily, 500 mg of clarithromycin twice daily and 1 g of amoxicillin twice daily) Exclusion Criteria: * Ingestion of antibiotics, bismuth, or proton-pump inhibitors within the prior 4 weeks * Use of non-steroidal anti-inflammatory drugs within the prior 4 weeks * Participants with allergic history to the medications used * Participants with previous gastric surgery * The coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia) * Pregnant women.

Outcomes

Primary Outcomes

Percentage of Participants With Successful Eradication of H. Pylori

Successful eradication of H. pylori is defined as (1) negative results of both rapid urease test and histology, or (2) a negative result of urea breath test at 4 weeks.

Time frame: Negative results of H.pylori 4 weeks after eradication

Data from ClinicalTrials.gov

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