Lyophilized bacterial lysates of: Haemophilus influenzae, Streptococcus (diplococcus) pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Moraxella (Branhamella/Neisseria) catarrhalis for Recurrent respiratory tract infections | Respiratory tract infections

Inclusion criteria

• {"criterion_text":"- 1. Age 75 years or older."}
• {"criterion_text":"- 2. At least 2 RTIs in the year preceding enrollment."}
• {"criterion_text":"- 3. Patients must have resided in the Healthcare Residence for at least 6 months and have an expected stay in the Healthcare Residence of at least 6 months according to the physician judgement"}
• {"criterion_text":"- 4. Signed informed consent. For participants unable to provide informed consent due to cognitive deficits, consent will be provided by a legally recognized representative or a patient trustee (pursuant to article 4 of law 22 December 2017, n. 219)."}
• {"criterion_text":"- 5. Have a life expectancy of at least one year according to the physician judgement."}

Exclusion criteria

• {"criterion_text":"- 1. Patients with known allergy or previous intolerance to the study drug"}
• {"criterion_text":"- 2. Patients with active neoplasm and prognosis of less than one year"}
• {"criterion_text":"- 3. Patients with previous organ transplant"}
• {"criterion_text":"- 4. Patients treated with the following drugs: immunosuppressive or immunostimulatory therapy in the 3 months before the start of the study"}
• {"criterion_text":"- 5. Patients who have taken bacterial lysates in the 6 months prior to enrollment or who are currently using them"}
• {"criterion_text":"- 6. Patients treated regularly with oral corticosteroids"}
• {"criterion_text":"- 7. Patients who are unable to follow instructions and unreliable patients (including patients with alcoholism or patients unwilling to give informed consent or comply with protocol requirements)."}
• {"criterion_text":"- 8. Patients with any other clinical condition that, in the opinion of the investigator, would not allow the protocol to be completed and the study drugs to be administered safely."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Number of respiratory tract infections (RTIs) in the two groups measured during the 6-month treatment period and for a further 6-month observation period after start of administration of OM85 or placebo."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Rate of hospital admissions and emergency room visits in the 12 months following start of intervention, compared between OM85 and placebo groups."}
• {"endpoint_text":"- consumption of antibiotics in the 12 months following the start of the intervention","definition_or_measurement_approach":"Antibiotic prescriptions/consumption measured over the 12 months following start of intervention in each group."}
• {"endpoint_text":"- evaluation of the incidence of adverse events of OM-85 in elderly patients at risk by reviewing medical records","definition_or_measurement_approach":"Incidence of adverse events (TEAEs) collected by reviewing medical records of participants receiving OM-85 compared to placebo."}

Methods

• Decentralized recruitment: The Investigator will identify the medical staff of the Healthcare Residences (RSAs) who will participate in the study and will entrust them with the enrollment of patients according to the inclusion and exclusion criteria described (as specified in sponsor duties for participating RSAs).

Italy

Earliest CTIS Part Ii Submission Date

28-08-2024

Latest Decision Or Authorization Date

05-02-2026

Processing Time Days

526

Number Of Sites

1

Number Of Participants

360

Primary sponsor

Full Name

Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"G.A.29 S.r.l.","duties_or_roles":"As a decentralized study, the Investigator will identify the medical staff of the RSAs who will participate in the study and to whom he will entrust the enrollment of patients according to the inclusion and exclusion criteria described.","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Italy","full_name":"Paob S.r.l.","duties_or_roles":"As a decentralized study, the Investigator will identify the medical staff of the RSAs who will participate in the study and to whom he will entrust the enrollment of patients according to the inclusion and exclusion criteria described.","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Italy","full_name":"R.S.A. La Quiete S.r.l.","duties_or_roles":"As a decentralized study, the Investigator will identify the medical staff of the RSAs who will participate in the study and to whom he will entrust the enrollment of patients according to the inclusion and exclusion criteria described.","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Italy","full_name":"Villa Santo Stefano S.r.l.","duties_or_roles":"As a decentralized study, the Investigator will identify the medical staff of the RSAs who will participate in the study and to whom he will entrust the enrollment of patients according to the inclusion and exclusion criteria described.","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Italy","full_name":"Salus S.r.l.","duties_or_roles":"As a decentralized study, the Investigator will identify the medical staff of the RSAs who will participate in the study and to whom he will entrust the enrollment of patients according to the inclusion and exclusion criteria described.","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Italy","full_name":"Provincia Romana Dell'Ordine Dei Chierici Regolari Ministri Degl Infermi","duties_or_roles":"As a decentralized study, the Investigator will identify the medical staff of the RSAs who will participate in the study and to whom he will entrust the enrollment of patients according to the inclusion and exclusion criteria described.","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Italy","full_name":"Alpha Service S.r.l.","duties_or_roles":"As a decentralized study, the Investigator will identify the medical staff of the RSAs who will participate in the study and to whom he will entrust the enrollment of patients according to the inclusion and exclusion criteria described.","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Italy","full_name":"Casa Gen.Zia Del Pio Istituto Piccole Suore Della Sacra Famiglia","duties_or_roles":"As a decentralized study, the Investigator will identify the medical staff of the RSAs who will participate in the study and to whom he will entrust the enrollment of patients according to the inclusion and exclusion criteria described.","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Italy","full_name":"Sogepi S.r.l.","duties_or_roles":"As a decentralized study, the Investigator will identify the medical staff of the RSAs who will participate in the study and to whom he will entrust the enrollment of patients according to the inclusion and exclusion criteria described.","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Italy","full_name":"San Germano S.r.l.","duties_or_roles":"As a decentralized study, the Investigator will identify the medical staff of the RSAs who will participate in the study and to whom he will entrust the enrollment of patients according to the inclusion and exclusion criteria described.","organisation_type":"Hospital/Clinic/Other health care facility"}