NCT00520949

Quadruple Therapy for Triple Therapy Resistant Helicobacter Pylori Infection

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Treatment of Helicobacter Pylori

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-08-27
• Last updated: 2009-04-08

Locations

1 site across 1 country: Pakistan