Quadruple Therapy for Triple Therapy Resistant H. Pylori Infection - Full Text View

Purpose

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 7-14 days.

Condition	Intervention
Treatment of Helicobacter Pylori	Drug: Quadruple therapy

ChemIDplus related topics:

Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium Amoxicillin-potassium clavulanate combination Clavulanic acid Bismuth citrate Bismuth

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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

Further study details as provided by Aga Khan University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Safety of the quadruple therapy [ Time Frame: 6 weeks ]

Estimated Enrollment:	48
Study Start Date:	October 2006
Estimated Study Completion Date:	December 2007

Intervention Details:

Amoxicillin-clavulanic acid 1gram b.i.d; furazolidone 200mg b.i.d; colloidal bismuth subcitrate 240mg b.i.d;esomeprazole 40mg b.i.d for 14 days.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520949

Contacts


Contact: Zaigham Abbas, FACG	92214930051 ext 4659	zaigham@akunet.org

Contact: Javed Yakoob, PhD	92214864679	yakoobjaved@hotmail.com

Locations


Pakistan, Sindh
	Aga Khan University Hospital	Recruiting
	Karachi, Sindh, Pakistan, 74800
	Contact: Zaigham Abbas, FACG 92214930051 zaigham@akunet.org
	Principal Investigator: Zaigham Abbas, FACG
	Sub-Investigator: Javed Yakoob, PhD
	Sub-Investigator: Shahab Abid, FRCP
	Sub-Investigator: Wasim Jafri, FACG

Sponsors and Collaborators

Aga Khan University

Investigators


Principal Investigator:	Zaigham Abbas, FACG	Aga Khan University

More Information

Study ID Numbers:	609-Med
First Received:	August 24, 2007
Last Updated:	August 24, 2007
ClinicalTrials.gov Identifier:	NCT00520949
Health Authority:	Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:

H.pylori

Triple therapy failure

Quadruple therapy

Study placed in the following topic categories:

Bismuth tripotassium dicitrate

Amoxicillin

Clavulanic Acid

Omeprazole

Clavulanic Acids

Amoxicillin-Potassium Clavulanate Combination

Bismuth

Additional relevant MeSH terms:

Anti-Infective Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Anti-Ulcer Agents

Gastrointestinal Agents

Antacids

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2008

Sponsored by:	Aga Khan University
Information provided by:	Aga Khan University
ClinicalTrials.gov Identifier:	NCT00520949