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
12 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
Older adults living in nursing homes face a higher risk of respiratory infections compared to those living in the community. This research aims to evaluate if a bacterial lysate called OM 85 can reduce lower respiratory tract infections in this vulnerable population. The study focuses on people aged 75 and older who have experienced at least two respiratory tract infections in the previous year, addressing a gap in knowledge about the effects of OM 85 in elderly individuals with multiple health conditions. Participants will be randomly assigned to receive either the bacterial lysate OM 85 or a matching placebo. The lysate is given orally for 10 days each month over two cycles of three months each. The study will last for 12 months, during which researchers will compare the incidence of respiratory infections between the two groups. All participants will also receive recommended vaccines, ensuring consistent immunization across the study. Throughout the study, participants will be closely monitored for respiratory infections, hospital admissions, emergency room visits, and antibiotic use. Researchers will collect demographic, clinical, and functional data to understand factors linked to higher infection rates. Safety will be assessed by tracking any treatment-emergent adverse events. Participation involves regular evaluations over a year to gather comprehensive information on the effects of OM 85 in this older population.
CONDITIONS
Brief 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 past year
- Residing in nursing homes for at least 6 months with an expected stay of at least 6 months
- Signed informed consent or consent provided by a legally recognized 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 in the 3 months before study start
- Use of bacterial lysates in the 6 months before enrollment or current use
- Regular treatment with oral corticosteroids
- Inability to follow instructions or unreliable patients (including alcoholism or unwillingness to consent)
- Any other clinical condition that would prevent safe completion of the study protocol
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive oral bacterial lysate or placebo in two cycles of 10 days per month for 3 months each.
Multiple visits during two 3-month treatment cycles
Duration - 12 months
Participants are observed for respiratory tract infections and related health events for a total of 12 months from the start of treatment.
Periodic visits throughout the 12-month study period
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Campus Bio-Medico
Roma, RM, Italy, 00128
Actively Recruiting
Research Team
S
Silvia Travaglini, MD
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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