AZITHROMYCIN for Cellular senescence|Inflammatory status

Inclusion criteria

• {"criterion_text":"- •\tAge ≥ 60; ≤ 75 years\n- •\tNormal organ function (hepatic and renal)\n- •\tEstablished menopausal status for women (defined as no menses for 12 months)\n- •\tWritten informed consent"}

Exclusion criteria

• {"criterion_text":"- At least one of these:\n- •\tEvidence of an ongoing acute inflammatory event\n- •\tInfectious disease in progress\n- •\tInflammatory bowel disease\n- •\tAIDS\n- •\tActive neoplasms\n- •\tActive hematological diseases\n- •\tAutoimmune/rheumatologic diseases\n- •\tDiabetes\n- •\tSystemic therapy with anti-inflammatory drugs (NSAIDs, steroids, aspirin) during the 30 days preceding enrolment\n- •\tTherapy with immunomodulatory drugs: infliximab, adalimumab, golimumab, or etanercept for 90 days preceding enrolment\n- •\tSubjects with documented congenital or acquired QT interval prolongation\n- •\tTherapy with active substances that prolong the QT interval\n- •\tDisturbances in the balance of electrolytes in cases of hypokalaemia and hypomagnesemia\n- •\tClinically relevant bradycardia, cardiac arrhythmia, or severe heart failure\n- •\tKnown allergy to AZI\n- •\tOther experimental therapies in progress\n- •\tPrevious infection with C. difficile\n- •\tPatient have recieved an investigational drug within 30 days before screening or within five half-lives of the investigational product"}

Primary endpoints

• {"endpoint_text":"- Primary endpoints of this pilot study will be changes in 1) senescent cell abundance in the blood cells by p16INK4A evaluation; 2) other serum markers of aging/inflammaging","definition_or_measurement_approach":"Senescent cell abundance: by p16INK4A evaluation in blood cells; other endpoints: serum markers of aging/inflammaging (measurement details not specified)"}

Secondary endpoints

• {"endpoint_text":"- To determine the minimum effective dose","definition_or_measurement_approach":""}
• {"endpoint_text":"- To examine the safety","definition_or_measurement_approach":""}

Italy

Earliest CTIS Part Ii Submission Date

11-08-2025

Latest Decision Or Authorization Date

12-09-2025

Processing Time Days

32

Number Of Sites

1

Number Of Participants

12

Primary sponsor

Full Name

IRCCS Ospedale Policlinico San Martino

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Azienda Ospedaliera Di Perugia","duties_or_roles":"sponsorDuties code 8; contact: alessandro.darpino@ospedale.perugia.it","organisation_type":"Hospital/Clinic/Other health care facility"}