Quadruple Therapy for Triple Therapy Resistant Helicobacter Pylori Infection (QT-Hp)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00520949
Recruitment Status : Completed
First Posted : August 27, 2007
Last Update Posted : April 8, 2009
Information provided by:
Aga Khan University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Treatment of Helicobacter Pylori Drug: Augmentin (Amoxicillin-clavulanic) Drug: Furoxone (furazolidone) Drug: Cebes (colloidal bismuth subcitrate) Drug: Esso (esomeprazole) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Quadruple Therapy Using Esomeprazole, Colloidal Bismuth Subcitrate, Amoxicillin-Clavulanate, and Furazolidone in Patients Who Failed to Eradicate H. Pylori With Triple Therapy
Study Start Date : October 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Arm Intervention/treatment
Experimental: Quadruple Therapy 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

Primary Outcome Measures :
  1. Eradication of H. pylori infection resistant to triple therapy. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Safety of the quadruple therapy [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00520949

Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Principal Investigator: Zaigham Abbas, FACG Aga Khan University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Zaigham Abbas, The Aga Khan University Hospital Identifier: NCT00520949     History of Changes
Other Study ID Numbers: 609-Med
First Posted: August 27, 2007    Key Record Dates
Last Update Posted: April 8, 2009
Last Verified: April 2009

Keywords provided by Aga Khan University:
Triple therapy failure
Quadruple therapy

Additional relevant MeSH terms:
Amoxicillin-Potassium Clavulanate Combination
Bismuth tripotassium dicitrate
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors
Anti-Infective Agents, Local
Anti-Infective Agents, Urinary
Renal Agents
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents
Monoamine Oxidase Inhibitors