OM 85 to Prevent Respiratory Infections in Older At Risk Patients

ConditionRespiratory Tract Infections (RTI)

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Bacterial Lysate
Drug
Administration p.o. for 10 days per month for 3 months, two consecutive cycles.
Placebo
Drug
Matching placebo.

Treatment groups

360 Participants

are divided into 2 treatment groups

Group A: InterventionExperimental treatment 1 intervention

Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence of lower respiratory tract infections.

New cases of clinically-diagnosed lower respiratory tract infections

Time frame

12 months

Secondary outcomes

Rate of hospitalizations and emergency room admissions

Rate of hospitalizations and emergency room admissions due to respiratory tract infections.

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Campus Bio-Medico University

Lead sponsor

OM Pharma SA

Collaborator

Source ClinicalTrials.gov

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