Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT07178002
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Study:
NCT07178002
Study Brief:
Protocol Section:
NCT07178002