Quadruple Therapy for Triple Therapy Resistant Helicobacter Pylori Infection

Not Applicable

Completed

• Conditions: Treatment of Helicobacter Pylori
• Interventions: Drug: Augmentin (Amoxicillin-clavulanic); Drug: Furoxone (furazolidone); Drug: Cebes (colloidal bismuth subcitrate); Drug: Esso (esomeprazole)

• Registration Number: NCT00520949
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-08-24
• Study First Submitted QC: 2007-08-24
• Study First Posted: 2007-08-27
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-07
• Last Update Posted: 2009-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Quadruple Therapy	Augmentin (Amoxicillin-clavulanic)	-
Quadruple Therapy	Furoxone (furazolidone)	-
Quadruple Therapy	Cebes (colloidal bismuth subcitrate)	-
Quadruple Therapy	Esso (esomeprazole)	-

Primary Outcome Measures

Name	Time	Method
Eradication of H. pylori infection resistant to triple therapy.	6 weeks

Secondary Outcome Measures

Name	Time	Method
Safety of the quadruple therapy	6 weeks

Trial Locations

Locations (1)

Aga Khan University Hospital; 🇵🇰 Karachi, Sindh, Pakistan