Actively Recruiting
OM 85 to Prevent Respiratory Infections in Older At Risk Patients
Led by Campus Bio-Medico University · Updated on 2025-03-18
360
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
C
Campus Bio-Medico University
Lead Sponsor
O
OM Pharma SA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. Very little information is available on the effect of these substances in older people. This study will evaluate the efficacy of a bacterial lysate in reducing the incidence of lower respiratory tract infections in older people living in nursing homes. The study will include a treatment arm, in which participants will received the lysate, and a control arm in which participants will received a matching placebo (i.e., a pill that has the same appearance of the lysate but does not contain the lysate itself).
CONDITIONS
Official Title
OM 85 to Prevent Respiratory Infections in Older At Risk Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 75 years or older
- At least 2 respiratory tract infections in the year before enrollment
- Living in a nursing home for at least 6 months with an expected stay of at least 6 months
- Signed informed consent provided by participant or legally authorized representative
- Life expectancy of at least one year according to treating physician
You will not qualify if you...
- Known allergy or intolerance to any component of the study drug
- Active cancer with prognosis less than one year
- Previous organ transplantation
- Use of prohibited drugs within 3 months before the study
- Use of bacterial lysates within 6 months before enrollment or current use
- Regular treatment with oral corticosteroids
- Inability to follow instructions or unreliable compliance, including alcoholism or unwillingness to consent
- Any clinical condition that would prevent completing the study safely as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Campus Bio-Medico
Roma, RM, Italy, 00128
Actively Recruiting
Research Team
S
Silvia Travaglini, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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