Using bacterial lysate to prevent respiratory infections in older nursing home residents
OM 85 to Prevent Respiratory Infections in Older At Risk Patients
This study is testing if a bacterial treatment can help older nursing home residents who often get respiratory infections stay healthier and have fewer infections.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Campus Bio-Medico University Academic / other |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT06655272 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy of OM 85, a bacterial lysate, in reducing the incidence of lower respiratory tract infections among older adults living in nursing homes. Participants aged 75 and older, who have experienced at least two respiratory infections in the past year, will be randomly assigned to receive either the bacterial lysate or a placebo. The study aims to determine if this immunostimulating treatment can enhance the immune response and lower infection rates in this vulnerable population. The research is particularly focused on older individuals who may have unique health challenges due to age-related immune decline and multiple chronic conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 75 and older who reside in nursing homes and have had at least two respiratory infections in the previous year.
Not a fit: Patients with known allergies to the study drug components or those with active neoplasia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the frequency of respiratory infections in older nursing home residents, improving their overall health and quality of life.
How similar studies have performed: Previous studies have shown that bacterial lysates can effectively reduce respiratory infections in other populations, but this specific approach in the elderly is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 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 Criteria: * 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
Where this trial is running
Roma, RM
- Fondazione Policlinico Campus Bio-Medico — Roma, Rm, Italy (Recruiting)
Study contacts
- Study coordinator: Silvia Travaglini, MD
- Email: silvia.travaglini@unicampus.it
- Phone: +39 06 22541
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.