Sequential and Hybrid Therapies for H Pylori Infection
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary: To evaluate efficacy of 14 day 2-phase sequential therapy given in two forms. One in
      which the first component consists of a proton pump inhibitor and amoxicillin given for 7
      days followed by the PPI, clarithromycin and metronidazole for 7 days. The alternate will be
      similar with the exception that the amoxicillin will be continued throughout the 14 days. The
      secondary endpoint is to evaluate the effectiveness of therapy in relation to antibiotic
      resistance.
    

Detailed description: 
      The purpose of this study is to test whether the 14-day sequential therapy ( esomeprazole
      plus amoxicillin dual therapy for 7 days followed by triple therapy with esomeprazole,
      clarithromycin, and metronidazole for 7 days) or 14-day hybird therapy (esomeprazole plus
      amoxicillin dual therapy for 7 days followed by quadruple therapy with esomeprazole,
      amoxicillin, clarithromycin, and metronidazole for 7 days) can achieve an eradication rate
      equal to or more than 95%.

      A total of 240 subjects will be asked to participate in this study.

      H. pylori-infected patients are randomized to either a 14-day sequential therapy
      (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40
      mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days) or a hybrid
      therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by
      esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice
      daily for 7 days).

      Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and
      histological examination eight weeks after the end of anti-H. pylori therapy. The eradication
      rates of the two study groups will be compared.

      A successful regimen is defined as a regimen achieving an eradication rate equal to or more
      than 95%.
    

Intervention name(s): 14-day sequential treatment; 14-day hybrid treatment
Intervention type(s): Drug; Drug
Intervention description(s): 14-day sequential therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
14-day hybrid therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days; esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
Other intervention name(s): Esomeprazole, amoxicillin, clarithromycin, metronidazole; esomeprazole + amoxicillin, then quadruple therapy
Intervention MeSH terms: Amoxicillin; Metronidazole; Clarithromycin; Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Helicobacter pylori infection