Optimized-dose Amoxicillin Versus Standard-dose Amoxicillin for Quadruple Therapy in Helicobacter Pylori Eradication
Condition: Helicobacter Pylori
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this prospective randomized clinical trial is to compare the rate of Helicobacter
      Pylori (HP) eradication after standard or dose-optimized amoxicillin quadritherapy in
      patients naïve to any anti-HP treatment and with chronic HP infection documented by
      histological examination. The main questions it aims to answer are:

        -  compare the eradication rate of H.Pylori after a standard concomitant quadritherapy with
           2g of amoxicillin versus an optimized quadritherapy with 3g of amoxicillin, in Tunisian
           population

        -  Identify different factors associated with poor therapeutic response Patients were
           randomly assigned to either standard quadruple therapy (Qs-14: amoxicillin 1g twice
           daily, clarithromycin 500mg twice daily, metronidazole 500mg twice daily and
           esomeprazole 40mg twice daily for 14 days), or optimized quadruple therapy (Qo-14:
           amoxicillin 1g three times a day, clarithromycin 500mg twice daily, metronidazole 500mg
           twice daily and esomeprazole 40mg twice daily for 14 days). Eradication control was
           performed by urea breath test.
    

Detailed description: 
      This study was a prospective, randomized, single-center study conducted in the
      hepato-gastroenterology department of Mahmoud Matri Hospital in Ariana, in collaboration with
      the bacteriology and biochemistry laboratory of the same hospital, the anatomopathology
      department of Abderrahmen Mami Hospital in Ariana, and the private clinical analysis
      laboratory "Fendri". all patients aged from 18 and 65 years-old with H. pylori infection
      documented by pathological examination of per endoscopic gastric biopsies were recruited.

      This was a population of patients who had undergone upper endoscopy (UE) and in whom the
      search for H.Pylori was indicated, according to the European Maastrich IV recommendations.

      Eligible subjects were randomly assigned in a 1:1 ratio to receive either standard quadruple
      therapy (Qs-14) including : amoxicillin 1g twice daily ,clarithromycin 500mg twice daily
      ,metronidazole 500mg twice daily and esomeprazole (Medis Pharmaceutical Company) 40 mg twice
      daily for 14 days, or optimized quadruple therapy (Qo-14) including : amoxicillin 1g three
      times daily ,clarithromycin 500mg twice daily, metronidazole 500mg twice daily and
      esomeprazole 40 mg twice daily (Medis Pharmaceutical Company) for 14 days.

      Eradication control was performed by 13C-UBT at least 4 weeks after the end of the treatment.
    

Intervention name(s): optimized quadruple therapy; standard quadruple therapy
Intervention type(s): Drug; Drug
Intervention description(s): Association of amoxicillin 3 g/day + Esomeprazole, nitroimidazole and clarithromycin for 14 days; Association of amoxicillin 2 g/day + Esomeprazole, nitroimidazole and clarithromycin for 14 days
Other intervention name(s): Qo-14; Qs-14
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Disease Eradication