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Study on Preventing Respiratory Infections in Elderly Patients Using OM85

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on preventing respiratory infections in elderly patients who have experienced at least two such infections in the past year. The study will use a medication called OM85, which is made from lyophilized bacterial lysates. This means it contains small parts of bacteria that are processed in a way to potentially help the body build a defense against infections. The trial will compare the effects of OM85 to a placebo to see if it can reduce the number of respiratory infections over a 12-month period.

The study will involve elderly patients living in healthcare residences. Participants will receive either OM85 or a placebo for six months, and their health will be monitored for an additional six months. The main goal is to see if OM85 can lower the number of respiratory infections. Additionally, the study will look at other factors such as hospital admissions, emergency room visits, and the use of antibiotics during the 12 months following the start of the treatment.

Throughout the study, researchers will also review medical records to check for any side effects of OM85 in elderly patients. This trial aims to provide valuable information on whether OM85 can be an effective way to prevent respiratory infections in older adults who are at risk.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Eligibility is confirmed based on age (75 years or older), history of at least two respiratory infections in the past year, and residence in a healthcare facility for at least six months.

    Informed consent is required. If unable to provide consent, a legally recognized representative or trustee will do so.

  2. Step 2

    Initial assessment

    A comprehensive health assessment is conducted to establish a baseline for the study.

    This includes reviewing medical history and current health status.

  3. Step 3

    Treatment phase

    The treatment involves taking OM85 or a placebo orally.

    The medication is administered in the form of a hard capsule, with a dosage of 7 mg.

    The treatment period lasts for 6 months.

  4. Step 4

    Monitoring

    During the treatment phase, the number of respiratory infections is monitored.

    Any hospital admissions, emergency room visits, and antibiotic use are recorded.

    The incidence of any adverse effects is evaluated by reviewing medical records.

  5. Step 5

    Observation period

    After the treatment phase, a further 6-month observation period begins.

    The focus remains on tracking respiratory infections and healthcare utilization.

  6. Step 6

    Final assessment

    A final health assessment is conducted to evaluate the overall impact of the treatment.

    The study aims to determine the effectiveness of OM85 in reducing respiratory infections.

Who can join the trial?

5 criteria

  • Be **75 years or older**.
  • Have had **at least 2 respiratory tract infections** in the year before joining the study. A respiratory tract infection is an illness that affects the parts of the body involved in breathing, like the lungs or throat.
  • Have lived in a **Healthcare Residence** for at least 6 months and be expected to stay there for at least another 6 months, as determined by a doctor. A Healthcare Residence is a place where people receive medical care and support.
  • Provide **signed informed consent**. If a participant cannot give consent due to memory or thinking problems, a legally recognized representative or a patient trustee can provide it on their behalf.
  • Have a **life expectancy of at least one year**, as determined by a doctor. Life expectancy is an estimate of how long a person is expected to live.

Who cannot join the trial?

3 criteria

  • Patients who have not had at least two infections of the breathing system in the past year.
  • Patients who have not lived in a Healthcare Residence for at least 6 months.
  • Patients who are not elderly.
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Investigated drugs

OM85 is a medication being studied for its potential to prevent respiratory infections in elderly patients. It is designed to help the immune system better defend against infections that affect the respiratory tract. The trial aims to see if OM85 can reduce the number of respiratory infections over a year in older adults who have had multiple infections in the past.

What is already known about the treatment

OM85 – OM85 is administered orally in the form of capsules. It is currently being studied in clinical trials to assess its effectiveness in preventing respiratory infections, particularly in elderly patients who have experienced multiple infections in the past year. The main therapeutic indication for OM85 is the prevention of respiratory tract infections. At the molecular level, OM85 works by stimulating the immune system, enhancing the body's natural defense mechanisms against pathogens. It is classified pharmacologically as an immunostimulant.

Investigated diseases

Respiratory Tract Infections – These infections affect parts of the respiratory system, such as the sinuses, throat, airways, or lungs. They can be caused by viruses or bacteria and are common in elderly individuals, especially those with a history of frequent infections. Symptoms may include coughing, sneezing, congestion, and difficulty breathing. The progression can vary, with some infections resolving quickly while others may lead to more severe respiratory issues. In elderly patients, these infections can recur frequently, especially in communal living environments like healthcare residences. The study focuses on reducing the frequency of these infections in such populations.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2024-513592-41-00Protocol codeOM 85OLDEREstimated enrolment360 patientsSponsorFondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon

sourced from the EU Clinical Trials Register and site verification

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