Bacterial Lysate: Administration p.o. for 10 days per month for 3 months, two consecutive cycles.
Placebo: Matching placebo.
Study 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
Sex
ALL
Min age
75 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Incidence of lower respiratory tract infections. — 12 months New cases of clinically-diagnosed lower respiratory tract infections
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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