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临床试验/NCT02368470
NCT02368470Unknown3 期

Randomized Study on Efficacy of Gemifloxacin-based Regimen for Helicobacter Pylori Infection

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 252 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
252
试验地点
1
主要终点
Helicobacter pylori eradication rate

研究概览

简要总结

New generations of fluoroquinolones, like levofloxacin and moxifloxacin, exhibit a broad-spectrum activity against Gram-positive and Gram-negative bacteria, and have been successfully introduced into the treatment of Helicobacter pylori infection. However, it was suggested that resistance to fluoroquinolones has been increasing in the Korean population and the resistance is most likely mediated through point mutation in gyrA. Gemifloxacin (FACTIVE®) is an enhanced-affinity, broad-spectrum fluoroquinolone suitable for once-daily, oral dosing. In vitro studies have shown that gemifloxacin displays potent activity against Gram-positive organisms, whilst retaining good activity against Gram-negative organisms. Gemifloxacin is the most potent member of the quinolone class against S. pneumoniae with activities 16-64 times greater than those of ciprofloxacin and ofloxacin and 2-8 times greater than those of moxifloxacin. Importantly, gemifloxacin displays potent in vitro activity against strains of S. pneumoniae with known resistance to β-lactams, macrolides and other members of the quinolone class. This potent activity is believed to be due to the enhanced affinity of gemifloxacin for topoisomerase IV, the major fluoroquinolone target in S. pneumoniae. Furthermore, gemifloxacin displays potent activity against H. influenzae and M. catarrhalis and atypical organisms such as L. pneumophila, C. pneumoniae and M. pneumoniae. It has proven particularly effective in respiratory and urinary tract infection.

详细描述

The purpose of this study is to compare the efficacy and the safety of using standard triple therapy and gemifloxacin-containing triple therapy as a first-line treatment for Helicobacter pylori eradication in Korea.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 19-70 years with H. pylori infection
  • The presence of H. pylori was defined as positive if the results of one of the following two tests were positive:
  • Rapid urease test (CLO™, Delta West, Bentley, Western Austria)
  • Histology. Biopsy specimens, obtained by endoscopy, were fixed in formalin and used for determination of H. pylori infection by Giemsa staining.

排除标准

  • Patients with previous H. pylori eradication therapy
  • Patients treated with H2 receptor antagonist, PPI, and antibiotics in the previous 4 weeks, or nonsteroidal anti-inflammatory drug (NSAID) in the previous 2 weeks
  • Pregnant or lactating women
  • Patients who suffered from serious diseases such as severe liver disease, renal disease, and cerebrovascular disease
  • Patients who had a drug allergy to the study drugs
  • Patients with previous gastric surgery.

研究组 & 干预措施

Standard triple therapy

Active Comparator

Rabeprazole (Rabiet®, ildong pharmaceutical Co. Ltd., Seoul, Korea) 20 mg twice daily, amoxicillin (Pamoxin®, Dongwha Co. Ltd., Seoul, Korea) 1 g twice daily, and clarithromycin (Klaricid®, Abbot Korea Co. Ltd., Seoul, Korea) 500 mg twice daily for 7 days

干预措施: Standard triple therapy (Drug)

Gemifloxacin-based triple therapy

Experimental

Rabeprazole (Rabiet®, ildong pharmaceutical Co. Ltd., Seoul, Korea) 20 mg twice daily, amoxicillin (Pamoxin®, Dongwha Co. Ltd., Seoul, Korea) 1 g twice daily, and gemifloxacin (Factive®, LG Life Sciences, Ltd, Seoul, Korea) 320 mg once daily for 7 days

干预措施: Gemifloxacin-based triple therapy (Drug)

结局指标

主要结局

Helicobacter pylori eradication rate

时间窗: up to 10 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyuk Lee

Assistant professor

Samsung Medical Center

研究点 (1)

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