An observational multicenter study on antibiotic resistance of Helicobacter pylori in France (PHARE)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Observational multicenter study

Study drug and medical condition

• Medical condition to be studied:
  Helicobacter infection

Population studied

• Short description of the study population:
  The study population was defined as being comprised of patients 18 years of age and older who had a scheduled or planned endoscopy at one of the centers involved in the study, who exhibited a pathology potentially associated with an infection by H. pylori or who had failure of a previous treatment for eradication, and who signed the information consent.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Helicobacter pylori infected patients
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  To assess the resistance rate in clinical isolates of Helicobacter pylori to antibiotics(clarithromycin, levofloxacin, tetracycline, rifamycin, amoxicillin and metronidazole).
• Outcomes:
  Resistance rate in clinical isolates of Helicobacter pylori to antibiotics (clarithromycin, levofloxacin, tetracycline, rifamycin, amoxicillin and metronidazole). - Trend in strain resistance over 5-year period following the commercial launch of PYLERA®. - To evaluate the impact of evolution of strain resistance to antibiotics on the efficacy to PYLERA® treatment.
• Data analysis plan:
  The resistance of Helicobacter pylori to six different antibiotics will be determined by agar diffusion using two different tests: disk diffusion for tetracycline, rifampicin (for rifamycin resistance), and levofloxacin, and Epsilometer test (E-tests) for clarithromycin, metronidazole and amoxicillin. Real time PCR for molecular characterization of resistance mutations associated to clarithromycin resistance will be performed on a subset of strains.