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

Samsung Medical Center

Status and phase: Unknown; Phase 3

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Gemifloxacin-based triple therapy; Drug: Standard triple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02368470

SMC 2014-07-146-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 252 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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252 participants in 2 patient groups

Standard triple therapy

Active Comparator group

Description:

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

Treatment:

Drug: Standard triple therapy

Gemifloxacin-based triple therapy

Experimental group

Description:

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

Treatment:

Drug: Gemifloxacin-based triple therapy