Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, Concomitant therapy, Sequential therapy, levofloxacin
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
Interventions
DRUGEradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)
amoxicillin tablets 1 g; esomeprazole tablets 40mg; tinidazole tablets 500mg; levofloxacin tablets 500 mg
Sponsors
University of Campania Luigi Vanvitelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication Rate | 1 year | The eradication rate obtained with the two treatments will be evaluated in the per-protocol and intention-to-treat analyses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 1 year | The incidence of adverse events during therapy will be assessed: bad taste, taste alteration, nausea, vomiting, diarrhoea, epigastric pain, glossitis, headache |
| Costs of either regimen | 1 year | The costs related to each treatment will be determined |
Countries
Italy
Outcome results
None listed