A Phase 3 interventional study of Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin) in Helicobacter Pylori Infection, sponsored by University of Campania Luigi Vanvitelli. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-03-06.
Sponsored by University of Campania Luigi Vanvitelli · Phase 3, Interventional, and Treatment
A five day quadruple concomitant therapy is as effective and safe as a 10 day sequential therapy for eradication of H. pylori infection.
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
6,686 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 180 is above the median of 120 across 4,199 interventional studies indexed under Infections.
Browse Infections studies →University of Campania Luigi Vanvitelli is the lead sponsor of 170 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
5-day eradication regimen consisting in the concomitant administration of esomeprazole 40mg bid + amoxicillin 1g bid + levofloxacin 500mg bid + tinidazole 500mg bid
Drug: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)
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
Drug: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)
amoxicillin tablets 1 g; esomeprazole tablets 40mg; tinidazole tablets 500mg; levofloxacin tablets 500 mg
Also known as: proton pump inhibitors
Eradication Rate
The eradication rate obtained with the two treatments will be evaluated in the per-protocol and intention-to-treat analyses
Time frame: 1 year
Adverse events
The incidence of adverse events during therapy will be assessed: bad taste, taste alteration, nausea, vomiting, diarrhoea, epigastric pain, glossitis, headache
Time frame: 1 year
Costs of either regimen
The costs related to each treatment will be determined
Time frame: 1 year
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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University of Campania Luigi Vanvitelli