Helicobacter pylori infection MedDRA version: 14.1 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Levofloxacin
Concentration number: NA-
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA' DEGLI STUDI DI NAPOLI
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Allergy or controindication to penicillin, quinolones, nitroimidazole compounds or PPI, pregnancy and under age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public ContactGastroenterologia
Azienda Ospedaliera Universitaria - SUN
Outcome results
None listed