Status:
ACTIVE_NOT_RECRUITING
OM 85 to Prevent Respiratory Infections in Older At Risk Patients
Lead Sponsor:
Fondazione Policlinico Universitario Campus Bio-Medico
Collaborating Sponsors:
OM Pharma SA
Conditions:
Respiratory Tract Infections (RTI)
Eligibility:
All Genders
7+ years
Phase:
PHASE4
Brief Summary
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 i...
Detailed Description
OM 85 (lyophilized bacterial lysate) proved effective in increasing the immune response against bacteria in animal models. Furthermore, its use was shown to be associated with lower incidence of RTIs ...
Eligibility Criteria
Inclusion
- 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 4 of Law No. 219 of December 22, 2017).
- Have a life expectancy of at least one year in the judgment of their treating physician.
Exclusion
- 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
Key Trial Info
Start Date :
December 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT07178002
Start Date
December 19 2024
End Date
April 1 2026
Last Update
September 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fondazione Policlinico Universitario Campus Bio Medico
Roma, Italia, Italy, 00128