NCT06655272 OM 85 to Prevent Respiratory Infections in Older At Risk Patients
| NCT ID | NCT06655272 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Campus Bio-Medico University |
| Condition | Respiratory Tract Infections (RTI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 360 participants in total. It began in 2025-02-01 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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).
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06655272 clinical trial?
This trial is open to participants of all sexes, aged 75 Years or older, studying Respiratory Tract Infections (RTI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06655272 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06655272 currently recruiting?
Yes, NCT06655272 is actively recruiting participants. Contact the research team at silvia.travaglini@unicampus.it for enrollment information.
Where is the NCT06655272 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06655272 clinical trial?
NCT06655272 is sponsored by Campus Bio-Medico University. The trial plans to enroll 360 participants.