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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
amoxicillin tablets 1 g; esomeprazole tablets 40mg; tinidazole tablets 500mg; levofloxacin tablets 500 mg
Dipartimento di Internistica Clinica e Sperimentale, SUN
Naples, Napoli, Italy
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
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