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Study of prevention of respiratory infections through the drug OM85 in elderly patients
EU CTIS ID: 2024-513592-41-00
What this study is testing
To evaluate whether and to what extent OM85 compared to placebo is able to reduce Respiratory Tract Infections (RTIs) in a period of 12 months in a population of elderly subjects, residing in Healthcare Residence, and with a history of at least two respiratory tract infections in the 12 months before enrollment.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age 75 years or older.
- 2. At least 2 RTIs in the year preceding enrollment.
- 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
- 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).
- 5. Have a life expectancy of at least one year according to the physician judgement.
You likely can't join if
- 1. Patients with known allergy or previous intolerance to the study drug
- 2. Patients with active neoplasm and prognosis of less than one year
- 3. Patients with previous organ transplant
- 4. Patients treated with the following drugs: immunosuppressive or immunostimulatory therapy in the 3 months before the start of the study
- 5. Patients who have taken bacterial lysates in the 6 months prior to enrollment or who are currently using them
- 6. Patients treated regularly with oral corticosteroids
See the full eligibility criteria
- 1. Age 75 years or older.
- 2. At least 2 RTIs in the year preceding enrollment.
- 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
- 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).
- 5. Have a life expectancy of at least one year according to the physician judgement.
- 1. Patients with known allergy or previous intolerance to the study drug
- 2. Patients with active neoplasm and prognosis of less than one year
- 3. Patients with previous organ transplant
- 4. Patients treated with the following drugs: immunosuppressive or immunostimulatory therapy in the 3 months before the start of the study
- 5. Patients who have taken bacterial lysates in the 6 months prior to enrollment or who are currently using them
- 6. Patients treated regularly with oral corticosteroids
- 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).
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.