Five-day Concomitant Versus 10-day Sequential Therapy for Eradication of Helicobacter Pylori Infection: a Randomized Trial of Levofloxacin-based Regimens
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Eradication Rate
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •H. pylori-infected patients who were at least 18 years of age and who had never received H. pylori eradication treatment were included in the study.
Exclusion Criteria
- •previous treatment for H. pylori infection,
- •use of inhibitors of acid secretion and/or antibiotics during the 6 weeks before the study,
- •gastrointestinal malignancy,
- •previous gastro-oesophageal surgery,
- •severe concomitant cardiovascular,
- •respiratory or endocrine diseases,
- •clinically significant renal or hepatic disease,
- •hematologic disorders,
- •any other clinically significant medical condition that could increase risk,
- •history of allergy to any of the drug used in the study,
- •pregnancy or lactation,
- •alcohol abuse,
- •drug addiction,
- •severe neurologic or psychiatric disorders, and
- •long-term use of corticosteroids or anti-inflammatory drugs.
Arms & Interventions
5d-QCT
5-day eradication regimen consisting in the concomitant administration of esomeprazole 40mg bid + amoxicillin 1g bid + levofloxacin 500mg bid + tinidazole 500mg bid
Intervention: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin) (Drug)
10-day sequential regimen
5 days of esomeprazole 40mg bid + amoxicillin 40mg bid followed by 5 more days of esomeprazole 40mg bid + levofloxacin 500mg bid + tinidazole 500 mg bid
Intervention: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin) (Drug)
Outcomes
Primary Outcomes
Eradication Rate
Time Frame: 1 year
The eradication rate obtained with the two treatments will be evaluated in the per-protocol and intention-to-treat analyses
Secondary Outcomes
- Adverse events(1 year)
- Costs of either regimen(1 year)
Investigators
Marco Romano
Associate Professor of Gastroenterology
University of Campania "Luigi Vanvitelli"