BridgeMD
New treatment option for Respiratory Tract Infections (RTI)
Official title OM 85 to Prevent Respiratory Infections in Older At Risk Patients
ClinicalTrials.gov ID: NCT06655272
What this study is testing
What is Bacterial Lysate?
Bacterial Lysate is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for respiratory tract infections (rti).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- People living in NH are at higher risk of respiratory infections compared to their counterpart living in the community. Products obtained from dead bacteria ("bacterial lysate") can be used to boost immune system and may reduce the risk of respiratory infections.
- Phase 4: studies an already-approved treatment
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 75 and older
You may be able to join if
- Age 75 years or older
- At least 2 RTIs in the year prior to enrollment
- Patients must have been residing in nursing homes for at least 6 months and have an estimated length of stay in nursing homes of at least 6 months by...
- Signed informed consent. If participants are unable to provide informed consent due to cognitive impairment, consent will be provided by a legally...
- Have a life expectancy of at least one year in the judgment of their treating physician.
You likely can't join if
- Patients with known allergy or previous intolerance to any component (including the excipient) of the study drug
- Patients with active neoplasia and prognosis of less than one year
- Patients with previous organ transplantation
- Patients treated with prohibited drugs (see Table 1) in the 3 months prior to the start of the study
- Patients who have taken bacterial lysates in the 6 months prior to enrollment or are currently using them
- Patients regularly treated with oral corticosteroids
See the full eligibility criteria
- Age 75 years or older
- At least 2 RTIs in the year prior to enrollment
- Patients must have been residing in nursing homes for at least 6 months and have an estimated length of stay in nursing homes of at least 6 months by their treating physician.
- Signed informed consent. If participants are unable to provide informed consent due to cognitive impairment, consent will be provided by a legally recognized representative or trustee of the patient (pursuant to Article...
- Have a life expectancy of at least one year in the judgment of their treating physician.
- Patients with known allergy or previous intolerance to any component (including the excipient) of the study drug
- Patients with active neoplasia and prognosis of less than one year
- Patients with previous organ transplantation
- Patients treated with prohibited drugs (see Table 1) in the 3 months prior to the start of the study
- Patients who have taken bacterial lysates in the 6 months prior to enrollment or are currently using them
- Patients regularly treated with oral corticosteroids
- Patients unable to follow instructions and unreliable patients (including patients with alcoholism or patients unwilling to give informed consent or comply with protocol requirements)
- Patients with any other clinical condition that, in the opinion of the investigator, would not allow completion of the protocol and safe administration of the study drugs
The study team makes the final eligibility decision.
Where it's taking place
- Roma, RM, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 75 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, RM, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.