Concomitant therapy with levofloxacyn versus sequential therapy with levofloxacin for eradication of H. pylori infectio
- Conditions
- Helicobacter pylori infectionMedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2010-024644-15-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA' DEGLI STUDI DI NAPOLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
We will enroll, after obtaining informed consent, subjects of age 18 or more, male and female, infected with H. pylori as assessed by invasive (histology and/or RUT) or noninvasive (13C Urea Breath Test (UBT) and stool antigen) tests.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Allergy or controindication to penicillin, quinolones, nitroimidazole compounds or PPI, pregnancy and under age.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate whether a concomitant therapy with levofloxacin is equivalent to a sequential regimen containing levofloxacin for eradication of Helicobacter pylori infection;Secondary Objective: To evaluate side effects and patients’ compliance to eradication therapy and to evaluate cost implications.;Primary end point(s): to evaluate whether a concomitant therapy with levofloxacin is equivalent to a sequential regimen containing levofloxacin for eradication of Helicobacter pylori infection evaluedted with eradication rate
- Secondary Outcome Measures
Name Time Method