Quadruple Therapy for Triple Therapy Resistant Helicobacter Pylori Infection

Overview

Triple therapy, a combination of proton pump inhibitor with two antibiotics, is the gold standard for anti-Helicobacter pylori treatment. Usual antibiotics are clarithromycin, and either amoxicillin or one of the nitroimidazoles (metronidazole). However, there is an increasing evidence of H. pylori resistance to classical triple therapy. Another reason for this failure being low patient compliance with treatment. A regimen useful in one geographical area may not be effective or practical in another area. The aim of this study was to eradicate H. pylori infection resistant to triple therapy, establish the efficacy and safety of a 14-day therapeutic regimen to eradicate of H. pylori in patients who have failed with the classical triple therapy (omeprazole, clarithromycin and amoxicillin) given for 14 days.

Full Title of Study: “Quadruple Therapy Using Esomeprazole, Colloidal Bismuth Subcitrate, Amoxicillin-Clavulanate, and Furazolidone in Patients Who Failed to Eradicate H. Pylori With Triple Therapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2008

Interventions

  • Drug: Augmentin (Amoxicillin-clavulanic)
    • Amoxicillin-clavulanic acid 1 gram b.i.d
  • Drug: Furoxone (furazolidone)
    • furazolidone 200 mg b.i.d
  • Drug: Cebes (colloidal bismuth subcitrate)
    • colloidal bismuth subcitrate 240 mg b.i.d
  • Drug: Esso (esomeprazole)
    • esomeprazole 40 mg b.i.d for 14 days

Arms, Groups and Cohorts

  • Experimental: Quadruple Therapy

Clinical Trial Outcome Measures

Primary Measures

  • Eradication of H. pylori infection resistant to triple therapy.
    • Time Frame: 6 weeks

Secondary Measures

  • Safety of the quadruple therapy
    • Time Frame: 6 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Informed consent given by the patient – Patients known to have H. pylori infection diagnosed by histopathology, rapid urease test and urea breath test – Failure to respond to classical triple regime of amoxicillin 1gram, clarithromycin 500mg and omeprazole 20mg twice a day for 10-14 days as documented by repeat urea breath test done one month after eradication therapy Exclusion Criteria:

  • Evidence of any malignancy, gastric outlet syndrome, history of gastric surgery, chronic liver disease, severe chronic renal failure, or any major co-morbidity. – known or suspected hypersensitivity to the medication used in the study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aga Khan University
  • Provider of Information About this Clinical Study
    • Dr Zaigham Abbas, The Aga Khan University Hospital
  • Overall Official(s)
    • Zaigham Abbas, FACG, Principal Investigator, Aga Khan University

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