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

Buddhist Tzu Chi General Hospital

Status and phase: Terminated; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Levofloxacin-Amox/clav.; Drug: Clarithromycin-Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT01575899

IRB096-28

Details and patient eligibility

About

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.

Full 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.

Enrollment: 208 patients

Sex: All

Ages: 20 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

Levofloxacin-Amoxicillin/clavulanate

Experimental group

Description:

7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.

Treatment:

Drug: Levofloxacin-Amox/clav.

Clarithromycin-Amoxicillin

Active Comparator group

Description:

7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.

Treatment:

Drug: Clarithromycin-Amoxicillin