Azienda Ospedaliera Di Perugia
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Perugia, Italy
Not yet recruiting
Study of Azithromycin Effects on Cellular Aging Markers in Healthy Adult Volunteers
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This study investigates cellular senescence, which is a natural aging process of cells that can lead to inflammation in the body. The research focuses on testing azithromycin, an antibiotic medication, to understand how it affects aging cells in healthy individuals.
The study will evaluate different doses of azithromycin given as an oral suspension to determine its effects on cellular aging markers. The maximum daily dose will be 500 mg, and the treatment period will last up to three months. The research aims to find the most effective dose that could influence the aging process of cells.
During the study, researchers will examine blood samples to measure the levels of specific proteins and other substances that indicate cellular aging and inflammation. This will help determine how the medication affects the natural aging process at the cellular level. The study will also monitor the safety of using azithromycin for this purpose.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
6 criteria
- Age between 60 and 75 years old
- Must have normal liver and kidney function (normal organ function)
- For women participants: must be in menopause, meaning no menstrual periods for at least 12 months
- Must be able to understand and sign an informed consent form, which is a document explaining all study procedures and potential risks
- Both men and women can participate in the study
- Must not belong to any vulnerable population groups (such as people with impaired decision-making capacity)
Who cannot join the trial?
16 criteria
- Current or recent (within 3 months) participation in other clinical trials
- History of allergic reactions to azithromycin or similar antibiotics
- Pregnant women or those planning pregnancy during the study period
- Breastfeeding mothers
- Severe liver problems or abnormal liver function tests
- Severe kidney problems or impaired kidney function
- Current use of medications that could interact with azithromycin
- History of heart rhythm problems, especially prolonged QT interval (an abnormal heart electrical pattern)
- Active or chronic infections requiring antibiotic treatment
- Significant heart, lung, or blood disorders
- Uncontrolled diabetes or other serious metabolic conditions
- History of cancer within the past 5 years
- Mental health conditions that could affect ability to follow study procedures
- Substance abuse or alcohol dependency
- Unable to provide informed consent
- Any condition that, in the investigator's opinion, could compromise patient safety during the study
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Investigated drugs
Azithromycin is an antibiotic medication that belongs to the macrolide family. In this trial, it is being studied for its potential effects on cellular senescence (aging of cells). While it is commonly used to treat various bacterial infections, researchers are exploring its possible new role in affecting how cells age in healthy people.
What is already known about the treatment
Azithromycin – An oral or intravenous antibiotic medication belonging to the macrolide class of antibiotics, which is currently being investigated for its potential effects on cellular senescence and inflammation in clinical trials. The medication works by binding to bacterial ribosomes and preventing protein synthesis, but recent research suggests it may also have anti-inflammatory and immunomodulatory properties that could affect cellular aging processes. Traditionally used to treat bacterial infections of the respiratory tract, skin, and other body systems, azithromycin is now being studied in healthy volunteers to evaluate its potential new therapeutic applications in age-related conditions and inflammatory disorders.
Investigated diseases
Cellular Senescence
A natural biological process where cells permanently stop dividing but remain metabolically active. These senescent cells accumulate in various tissues and organs as people age. They release inflammatory substances that affect nearby healthy cells and contribute to age-related changes in the body. This condition is characterized by specific molecular markers, including increased expression of p16INK4A protein. The process gradually develops over time and is associated with chronic low-grade inflammation, often termed "inflammaging." Senescent cells can impact normal tissue function and repair processes.
Inflammaging
A chronic, low-grade inflammatory state that develops with advancing age. It is characterized by persistently elevated levels of inflammatory molecules in the body's tissues and bloodstream. The condition involves a complex interaction between various immune system components and can affect multiple organ systems simultaneously. This state of chronic inflammation progresses gradually over time and is closely connected to the aging process. The condition is marked by increased levels of inflammatory markers in the blood.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522379-26-00Protocol codeAZISENEstimated enrolment12 patientsSponsorIRCCS Ospedale Policlinico San Martino
sourced from the EU Clinical Trials Register and site verification
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