NCT01544517

5 Day Concomitant Versus 10 Day Sequential Therapy for Eradication of H. Pylori Infection

Five-day Concomitant Versus 10-day Sequential Therapy for Eradication of Helicobacter Pylori Infection: a Randomized Trial of Levofloxacin-based Regimens

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A five day quadruple concomitant therapy is as effective and safe as a 10 day sequential therapy for eradication of H. pylori infection.

Detailed description

The investigators studied 180 consecutive patients with H. pylori infection who were randomized to 5-day concomitant therapy (90 patients) and to 10-day sequential therapy (90 patients). 6 and 10 weeks after the end of therapy, patients were evaluated for their H. pylori status by 13C Urea Breath Test. Side effects and costs of either regimen were evaluated. In patients whose H pylori status at entry was assessed by endoscopy, culture was performed and antimicrobial resistance was determined

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)	amoxicillin tablets 1 g; esomeprazole tablets 40mg; tinidazole tablets 500mg; levofloxacin tablets 500 mg

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-05-01
• Completion: 2011-12-01
• First posted: 2012-03-06
• Last updated: 2012-03-06

Locations

1 site across 1 country: Italy