Test-and-treat Helicobacter pylori for gastric cancer prevention

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  amoxicillin (any available brand), ; clarithromycin (any available brand), ; levofloxacin (any available brand), ; metronidazole (any available brand), ; tetracycline (any available brand), ; esomeprazole (any available brand), and; colloidal bismuth (any available brand).
• Study drug International non-proprietary name (INN) or common name:
  AMOXICILLIN

  BISMUTH

  LEVOFLOXACIN HEMIHYDRATE

  METRONIDAZOLE

  TETRACYCLINE
• Anatomical Therapeutic Chemical (ATC) code:
  (A01AB13) tetracycline

  tetracycline

  (A01AB17) metronidazole

  metronidazole

  (A02BC05) esomeprazole

  esomeprazole

  (A02BX05) bismuth subcitrate

  bismuth subcitrate

  (J01CA04) amoxicillin

  amoxicillin

  (J01FA09) clarithromycin

  clarithromycin

  (J01MA12) levofloxacin

  levofloxacin
• Medical condition to be studied:
  Helicobacter infection

Population studied

• Age groups:
  Adults (18 to < 46 years)
• Estimated number of subjects:
  6800

Study design details

• Main study objective:
  The main objective of this study is to test the implementation of a screening program for Helicobacter pylori infection and treatment with the proposed "test-and-treat" strategy in six EU member states.
• Outcomes:
  1. Participation rate of patients invited into the program, ; 2. Eradication rate of infection with H. pylori, ; 3. Description of adverse events profile.
• Data analysis plan:
  1. Participation rate of patients invited into the program: descriptive calculation of rates. ; 2. Eradication rate of infection with H. pylori: descriptive calculation of rates. ; 3. Adverse events profile: qualitative (and descriptive) analysis.