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
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