Randomized Study on Efficacy of Gemifloxacin-based Regimen for Helicobacter Pylori Infection
Status:
Unknown status
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
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.