Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori

Phase 4TerminatedNCT01575899

Buddhist Tzu Chi General Hospital208 enrolled

Overview

This prospective controlled randomized open-label clinical trial is designed to determine the eradication rate of 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole regimen compared with 7-day standard triple therapy for adults infected with Helicobacter pylori in Eastern Taiwan.

BACKGROUND: The resistance rate of Helicobacter pylori (Hp) to amoxicillin and metronidazole therapy is significantly higher in Eastern Taiwan as compared to national and worldwide rates. The high resistance rate in this territory justified a search for a better eradication regimen for Hp infection. AIM: To evaluate the efficacy and tolerability of a combination therapeutic regimen of levofloxacin, amoxicillin/clavulanate and rabeprazole (LAcR) versus a conventional seven-day triple therapy with clarithromycin, amoxicillin and rabeprazole (CAR) for the eradication of Hp infection. METHODS: We conducted a open-labeled, prospective, randomized, controlled study in a large tertiary referral hospital in Eastern Taiwan. Hp-positive therapy-naïve patients with a positive CLO test as proven by gastroscopy were recruited for potential random assignment to two 7-day treatment groups: LAcR or CAR (control). The primary end point of this study was to evaluate the eradication rate of LAcR regimen. Hp eradication was assessed using the 13C-urea breath test or CLO test performed at least 4 weeks after end of treatment. Compliance and adverse effects with therapy were determined by phone call or outpatient clinic follow up. EXPECTED RESULT: The seven-day LAcR regimen evaluated in this study provided improved Hp eradication efficacy when compared with the traditional seven-day triple therapy in Eastern Taiwan.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

208

Conditions

Helicobacter Pylori Infection

Interventions

Levofloxacin-Amox/clav.DRUG

Levofloxacin, 500 mg b.i.d., amoxicillin/clavulanate, 875mg/125mg b.i.d. and rabeprazole, 20 mg b.i.d. for 7 days.

Clarithromycin-AmoxicillinDRUG

Clarithromycin, 500 mg b.i.d., amoxicillin, 1000 mg b.i.d. and rabeprazole 20 mg b.i.d. for 7 days.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 95 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient proved with infection of H. pylori in gastric mucosa * Patient with signed informed consent. Exclusion Criteria: * woman in breast feeding or pregnancy. * allergy or severe adverse effects to drugs used in study. * severe complications of peptic ulcer disease (like perforation or obstruction). * patients with history of cancer or failure of major organs.

Locations (1)

Buddhist Tzu Chi General Hospital

Hualien City, Taiwan, Taiwan

Outcomes

Primary Outcomes

Eradication Rate (Participants Naive to Anti-H. Pylori Treatment)

A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment.

Time frame: 4 weeks after complete use of drug for treatment

Secondary Outcomes

Eradication Rate of Participants Living in Rural Area.

Subgroup analysis on eradication rate (percentage of participants with a negative result of C13 or CLO test at least four weeks after treatment) according to resident area of participants, especially who are living in rural area.

Time frame: 4 weeks after complete use of drug for treatment

Data from ClinicalTrials.gov

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