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

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

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.

Study Overview

• Status: Terminated
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Levofloxacin-Amox/clav.; Drug: Clarithromycin-Amoxicillin

Detailed Description

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
• Enrollment (Actual): 208
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Hualien, Taiwan, 97002
    • Buddhist Tzu Chi General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Levofloxacin-Amoxicillin/clavulanate; 7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.	Drug: Levofloxacin-Amox/clav.; Levofloxacin, 500 mg b.i.d., amoxicillin/clavulanate, 875mg/125mg b.i.d. and rabeprazole, 20 mg b.i.d. for 7 days.; Other Names: Levofloxacin(Cravit), Amoxicillin/clavulanate(Augmentin) and; Rabeprazole(Pariet) for 7 days.
ACTIVE_COMPARATOR: Clarithromycin-Amoxicillin; 7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.	Drug: Clarithromycin-Amoxicillin; Clarithromycin, 500 mg b.i.d., amoxicillin, 1000 mg b.i.d. and rabeprazole 20 mg b.i.d. for 7 days.; Other Names: Rabeprazole(Pariet) for 7 days.; Clarithromycin(Klaricid), Amoxicillin(Hiconcil) and

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks after complete use of drug for treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks after complete use of drug for treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-eradication Rate	Re-eradication successful rate (percentage of participants with a negative result of C13 or CLO test at least four weeks after the 2nd treatment) with 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin.	4 weeks after complete use of drug for treatment

Collaborators and Investigators

• Sponsor: Buddhist Tzu Chi General Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: April 10, 2012
• First Submitted That Met QC Criteria: April 11, 2012
• First Posted (ESTIMATE): April 12, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 31, 2012
• Last Update Submitted That Met QC Criteria: July 28, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Levofloxacin; Rabeprazole; Amoxicillin/clavulanate; Eastern Taiwan
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Gastrointestinal Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; beta-Lactamase Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Rabeprazole; Amoxicillin; Clarithromycin; Levofloxacin; Ofloxacin; Clavulanic Acid; Amoxicillin-Potassium Clavulanate Combination
• Other Study ID Numbers: IRB096-28