Study of Azithromycin Effects on Cellular Aging Markers in Healthy Adult Volunteers

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What is this study about?

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.

1 Initial screening

Your eligibility for the study will be assessed based on the following criteria:

– Age between 60 and 75 years

– Normal liver and kidney function

– For women: confirmed menopause (no menstrual periods for at least 12 months)

Blood samples will be collected to evaluate your current health status

2 Study medication assignment

You will be assigned to receive Azithromycin (oral suspension)

The medication will be provided in the form of a liquid that you will take by mouth

You will be placed in one of three study groups, each receiving different doses of the medication

3 Treatment period

You will take Azithromycin oral suspension according to the prescribed schedule

Blood samples will be collected to measure markers of cellular aging

Your health status will be monitored throughout the treatment period

4 Follow-up evaluations

Regular blood tests will be performed to measure:

– Levels of p16INK4A (a marker of cellular aging) in your blood cells

– Other markers related to aging and inflammation in your blood

Your overall health and safety will be monitored throughout the study period

5 Study completion

Final blood samples will be collected

A complete health assessment will be performed

The study will conclude by October 2026

Who Can Join the Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Azienda Ospedaliera Di Perugia Perugia Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
01.10.2025

Trial locations

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.

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 ID:
2025-522379-26-00
Protocol code:
AZISEN
Trial Phase:
Therapeutic exploratory (Phase II)

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