A Trial of Standard vs Half Dose Rabeprazole, Clarithromycin, Metronidazole and Amoxicillin in the Treatment of Helicobacter Pylori Infection
Condition: Helicobacter Infections
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The proposed study will test the hypothesis that H. pylori can be eradicated successfully
      (>85%) using half-or full-dose "concomitant" non-bismuth quadruple therapy regimen:
      rabeprazole, amoxicillin, clarithromycin and metronidazole twice daily for 7 days in patients
      with peptic ulcers and H. pylori related gastritis.

      Two hundred patients from the outpatient department and the endoscopy unit at AUBMC will be
      enrolled in this open-label trial. Patients with positive CLO tests or urea breath tests,
      documenting H.pylori infection, will be randomized into one of two groups: Full dose or half
      dose the concomitant regimen, with 100 patients in each group. Compliance and side effects
      will be assessed, and a urea breath test will be done for all patients after 4 weeks of
      therapy completion to evaluate eradication rates. Success of therapy will be evaluated
      according to intent-to treat and per-protocol analyses.
    

Detailed description: 
      Infection with H. pylori has been linked with chronic active gastritis, peptic ulcer disease,
      adenocarcinoma and Non-Hodgkin's lymphoma of the stomach. Eradication of this organism has
      been recommended for patients with peptic ulcer disease, low-grade gastric mucosa-associated
      lymphoid tissue lymphoma, atrophic gastritis, unexplained iron deficiency anemia, chronic
      idiopathic thrombocytopenic purpura, as well as first-degree relatives of gastric cancer
      patients.

      Guidelines still recommend using triple therapy regimen of PPI, clarithromycin and
      amoxicillin/metronidazole twice daily for 7 to 14 days. Over the years, it has become clear
      that the first-line triple therapy is loosing efficacy worldwide with PP and ITT eradication
      rates inferior to 80%. Antimicrobial resistance plays an important role in some of these
      failures.

      Major H. pylori study groups in the world have agreed that alternative treatment regimens are
      urgently needed. So far, 2 alternative treatment regimens have shown superiority over the
      first-line treatment protocols: the sequential therapy consisting of a combination of
      amoxicillin and a PPI twice a day for 5 days followed by another 5 days of the PPI plus
      clarithromycin and tinidazole/metronidazole, and the concomitant non-bismuth quadruple
      regimen consisting of PPI, clarithromycin, metronidazole, and amoxicillin twice daily.

      The proposed study will test the hypothesis that H. pylori can be eradicated successfully
      (>85%) using half-or full-dose "concomitant" non-bismuth quadruple therapy regimen:
      rabeprazole, amoxicillin, clarithromycin and metronidazole twice daily for 7 days in patients
      with peptic ulcers and H. pylori related gastritis.

      Two hundred patients from the outpatient department and the endoscopy unit at AUBMC will be
      enrolled in this open-label trial. Patients with positive CLO tests or urea breath tests,
      documenting H.pylori infection, will be randomized into one of two groups: Full dose or half
      dose the concomitant regimen, with 100 patients in each group. Compliance and side effects
      will be assessed, and a urea breath test will be done for all patients after 4 weeks of
      therapy completion to evaluate eradication rates. Success of therapy will be evaluated
      according to intent-to treat and per-protocol analyses.
    

Intervention name(s): Rabeprazole, metronidazole, Clarithromycin, Amoxicillin
Intervention type(s): Drug
Intervention description(s): Full dose arm:Rabeprazole (20mg), metronidazole (500mg), Clarithromycin (500mg) and Amoxicillin (1000mg) twice daily for a period of 7 days.
Half dose arm: Rabeprazole (10mg), metronidazole (250mg), Clarithromycin (250mg) and Amoxicillin (500mg) twice daily for a period of 7 days.
Other intervention name(s): Rabeprazole: Pariet; Metronidazole: Flagyl; Clarithromycin: Klacid; Amoxicillin: Amoxil
Intervention MeSH terms: Amoxicillin; Metronidazole; Clarithromycin; Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori infection; quadruple therapy; Amoxicillin; Metronidazole; Clarithromycin; Rabeprazole