NCT01481844

Sequential Therapy Versus Quadruple Therapy as Second Line Treatment After Failure of the Standard Triple Therapy for H Pylori Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Soroka University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the efficacy of sequential therapy, i.e. 5 days of PPI + amoxicillin followed by 5 days of PPI + two antimicrobial drugs( clarithromycin and tinidazole ) versus quadruple drug regimen( i.e.-14 days of PPI+ bismuth + metronidazole + tetracycline ) as second line treatment of H. pylori .

Detailed description

a total of 101 patients were randomized to 2 groups : 50 in sequential group and 51 patients in quadruple group . mean age was 43 in both groups. In sequential therapy group 42 patients(84%) completed the treatment , 39 patients returned to follow up . In quadruple group only 33 patients (64.7%) completed the treatment , 29 of them returned to follow up. Compliance to the treatment was significant better in sequential group comparative to quadruple .Sides effects connected to gastro-intestinal tract were reported in 27(65.9%) of quadruple group patients and in 19(43.2%)of sequential group. The H pylori was eradicated in 23 of 39 patients in sequential group(59%), and in 19 of the 29 patients in quadruple group(65.5%). no comorbidities like smoking, diabetes or other influenced the efficacy of eradication. Sequential therapy showed the same eradication rate as second line treatment of H pylori as quadruple one, but was associated with better compliance and less adverse effects. Both treatments protocols failed to show an appropriate eradication rate in population of Southern Israel .

Conditions

• Optimization of Second Line Treatment Protocol for H Pylori Eradication

Interventions

Type	Name	Description
DRUG	Lansoprazole , Tab Amoxycillin , Tab Clarithromycin ,Tab Tinidazole	use of Sequential therapy as second line treatment for eradication H pylori currently Sequential therapy is indicated as first line treatment for H pylori eradication
DRUG	Lansoprazole, Bismuth Subsalicylate, Metronidazole, Tetracycline	this combination is standard of care as H pylori second line treatment

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-11-30
• Last updated: 2015-07-08

Locations

1 site across 1 country: Israel