OM 85 to Prevent Respiratory Infections in Older At Risk Patients

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age75+
SponsorCampus Bio-Medico University

About this trial

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

Qualifiers

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).

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Bacterial Lysate
  • Placebo

Treatment groups

360 Participants
are divided into 2 treatment groups

Sponsors and collaborators