Levofloxacin-containing Therapies In Second Line Helicobacter Pylori Eradication

Helicobacter Pylori Infection Clinical Trial

Official title: The Efficacy of 10-day Metronidazole and Levofloxacin Containing Sequential Therapy and 10-day Levofloxacin-containing Triple Therapy In Second Line Helicobacter Pylori Eradication Therapies

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

• NCT number: NCT02596620
• Study type: Interventional
• Source: Chang Gung Memorial Hospital
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Completion date: November 2015