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Quadruple Therapy for Triple Therapy Resistant H. Pylori Infection

Information source: Aga Khan University
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Treatment of Helicobacter Pylori

Intervention: Quadruple therapy (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Aga Khan University

Official(s) and/or principal investigator(s):
Zaigham Abbas, FACG, Principal Investigator, Affiliation: Aga Khan University

Overall contact:
Zaigham Abbas, FACG, Phone: 92214930051, Ext: 4659, Email: zaigham@akunet.org

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 7-14 days.

Clinical Details

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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Primary outcome: Eradication of H. pylori infection resistant to triple therapy.

Secondary outcome: Safety of the quadruple therapy

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Zaigham Abbas, FACG, Phone: 92214930051, Ext: 4659, Email: zaigham@akunet.org

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

Starting date: October 2006
Ending date: December 2007
Last updated: August 24, 2007

Page last updated: February 12, 2009

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