Elderly patients with a positive history of at least two respiratory system infections in the year preceding enrollment and residents for at least 6 months in a Healthcare Residence.
Conditions
Brief summary
The measured variable will be the number of respiratory tract infections (RTIs) in the two groups during the treatment period (6 months) and until the end of the observation period (further 6 months) after the start of administration of OM 85 or placebo.
Detailed description
rate of hospital admissions and emergency room visits in the 12 months following the start of the intervention in the OM 85 or placebo group, consumption of antibiotics in the 12 months following the start of the intervention, evaluation of the incidence of adverse events of OM-85 in elderly patients at risk by reviewing medical records
Interventions
DRUGSame form and composition of the drug
DRUGexcept for the active ingredient.
DRUGBRONCHO VAXOM Adulti 7 mg capsule rigide
Sponsors
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured variable will be the number of respiratory tract infections (RTIs) in the two groups during the treatment period (6 months) and until the end of the observation period (further 6 months) after the start of administration of OM 85 or placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| rate of hospital admissions and emergency room visits in the 12 months following the start of the intervention in the OM 85 or placebo group, consumption of antibiotics in the 12 months following the start of the intervention, evaluation of the incidence of adverse events of OM-85 in elderly patients at risk by reviewing medical records | — |
Countries
Italy
Outcome results
None listed