Clinical trial NCT02368470: Randomized Study on Efficacy of Gemifloxacin-based Regimen for Helicobacter Pylori Infection
Official title: Randomized Study on Efficacy of Gemifloxacin-based Regimen for Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Helicobacter Pylori Infection
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-02-23
Enrollment: 252
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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:

  1. Rapid urease test (CLO™, Delta West, Bentley, Western Austria)
  2. Histology. Biopsy specimens, obtained by endoscopy, were fixed in formalin and used for determination of H. pylori infection by Giemsa staining.

Exclusion Criteria:

1. Patients with previous H. pylori eradication therapy
2. 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
3. Pregnant or lactating women
4. Patients who suffered from serious diseases such as severe liver disease, renal disease, and cerebrovascular disease
5. Patients who had a drug allergy to the study drugs
6. Patients with previous gastric surgery.

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: up to 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Hyuk Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: