Evaluation of OM85 for the Prevention of Respiratory Tract Infections in Elderly Patients with Recurrent Infections in Long-Term Care Facilities

The primary objective of this study is to evaluate the efficacy of **OM85** in reducing the incidence of **Respiratory Tract Infections (RTIs)** over a 12-month period in elderly patients residing in healthcare facilities, who have a history of at least two RTIs in the year prior to enrollment. This is clinically relevant as it aims to determine the potential of OM85 as a preventive measure against RTIs, which are a significant health concern in the elderly population, often leading to increased morbidity and healthcare utilization.

Secondary objectives include: - Verifying whether the rate of hospital admissions and emergency room visits due to RTIs decreases more in the OM85 group compared to the placebo group, using the year before the intervention as a reference. - Evaluating antibiotic prescriptions in both the OM85 and placebo groups during the 12 months of the study. - Defining the demographic, clinical, and functional profile of patients at risk of RTIs. - Evaluating the incidence of adverse drug reactions, specifically treatment-emergent adverse events (TEAEs).

The clinical trial involves a **population** of elderly subjects aged 75 years or older, both male and female, residing in a Healthcare Residence. Participants have a documented history of at least two **respiratory tract infections** (RTIs) in the year preceding enrollment. The trial focuses on individuals who have been residents of the Healthcare Residence for a minimum of six months and are expected to continue residing there for at least another six months, as per physician judgment. The study population is considered vulnerable due to their age and health status. The sponsor has not provided the total number of participants involved in the trial. Participants' lifestyle considerations, such as diet and physical activity, are not specified. Key inclusion criteria include a life expectancy of at least one year, and informed consent must be obtained, either directly from the participant or through a legally recognized representative if cognitive deficits are present.

The clinical trial is designed to evaluate the efficacy of **OM85** in reducing **respiratory tract infections** (RTIs) among elderly patients residing in healthcare facilities. This is a randomized, double-blind, placebo-controlled study, categorized as a Phase IV low-intervention trial. The trial will span a total duration of 12 months, with the treatment period lasting 6 months, followed by an additional 6-month observation period. Participants will be randomly assigned to receive either OM85 or a placebo, administered orally in the form of hard capsules. The primary endpoint is the number of RTIs recorded during the treatment and observation periods. Secondary endpoints include the rate of hospital admissions, emergency room visits, antibiotic consumption, and the incidence of adverse events.

Study visits are structured to ensure comprehensive monitoring and data collection. The initial inclusion visit, or screening, will confirm eligibility based on criteria such as age (75 years or older), a history of at least two RTIs in the previous year, and residency in a healthcare facility for at least 6 months. Participants must also have a life expectancy of at least one year. Follow-up visits will occur at regular intervals throughout the study to assess health status, adherence to the treatment regimen, and any adverse events. The end-of-study visit will conclude the trial, with a final evaluation of the participant's health and collection of outcome data.

Participant involvement is expected to last for the entire 12-month duration of the trial. However, early termination may occur if a participant withdraws consent, experiences significant adverse events, or if the investigator deems it necessary for the participant's safety. The trial aims to provide valuable insights into the potential benefits of OM85 in preventing RTIs in a vulnerable population, contributing to improved healthcare strategies for elderly patients.

The clinical trial involves the administration of **BRONCHO VAXOM Adulti 7 mg capsule rigide**, which is the experimental medication under investigation. This medication is presented in the form of a hard capsule and contains **lyophilized bacterial lysates** of several bacterial species, including **Haemophilus influenzae**, **Streptococcus (Diplococcus) pneumoniae**, **Klebsiella pneumoniae and ozaenae**, **Staphylococcus aureus**, **Streptococcus pyogenes and viridans**, and **Moraxella (Branhamella/Neisseria) catarrhalis**. The medication is administered orally, with a maximum daily dose of 7 mg and a total maximum dose of 420 mg over a treatment period of 60 days. The primary objective of the trial is to evaluate the efficacy of this medication in reducing respiratory tract infections in elderly patients over a 12-month period.

The study also includes a **placebo** group to serve as a comparator. The placebo is designed to match the experimental medication in form and composition, except for the active ingredient, ensuring that any observed effects can be attributed to the active substance. The placebo is administered in the same manner as the experimental medication, maintaining consistency in the route and frequency of administration. Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the protocol and to accurately assess the outcomes of the treatment.

Efficacy in this clinical trial will be assessed by evaluating the ability of OM85 compared to placebo to reduce **Respiratory Tract Infections (RTIs)** in elderly patients over a 12-month period. The primary endpoint is the number of RTIs occurring in the two groups during the treatment period of 6 months and continuing through the observation period, which extends for an additional 6 months after the initiation of OM85 or placebo administration. Secondary endpoints include the rate of hospital admissions and emergency room visits, the consumption of antibiotics, and the incidence of adverse events associated with OM85, all measured over the 12 months following the start of the intervention. Data collection will involve reviewing medical records to evaluate these parameters. The trial is designed as a phase IV, low-intervention study, adhering to the Marketing Authorization for the investigational medicinal product.