Study on Azithromycin and Doxycycline for Reducing Inflammation in Sarcoidosis Patients

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What is this study about?

This clinical trial is focused on studying a condition called . Sarcoidosis is a disease where small clusters of inflammatory cells, known as granulomas, form in different parts of the body, most commonly the lungs and lymph nodes. The trial will explore the effects of two medications, and , on reducing inflammation in patients with sarcoidosis. These medications are taken orally in the form of film-coated tablets.

The purpose of the study is to investigate whether treatment with azithromycin and doxycycline can decrease the inflammatory activity in patients with sarcoidosis. The study will also look at a specific type of sarcoidosis related to a bacterium called , which is sometimes found in and around the granulomas. The trial aims to see if the combination of these two medications can significantly reduce inflammation in this type of sarcoidosis.

Participants in the study will receive either the combination of azithromycin and doxycycline or a placebo. The study will monitor the effects of the treatment over a period of time to assess any changes in the inflammatory activity associated with sarcoidosis. The trial is designed to provide valuable insights into the potential benefits of these medications for managing sarcoidosis-related inflammation.

1 joining the study

Upon joining the study, participation is confirmed through a biopsy that proves the presence of sarcoidosis.

An initial scan, known as an FDG-PET scan, is conducted to assess inflammatory activity. This scan measures the SUVmax, a value indicating inflammation levels in the body.

2 medication administration

The treatment involves taking two types of antibiotics: doxycycline and azithromycin.

Doxycycline is administered orally in the form of a 100 mg film-coated tablet.

Azithromycin is administered orally in the form of a 500 mg film-coated tablet.

The specific dosage schedule and duration of administration are determined by the study protocol and communicated to the participant.

3 monitoring and evaluation

Throughout the trial, regular monitoring is conducted to evaluate the reduction of inflammation related to sarcoidosis.

The primary goal is to observe a decrease in inflammatory activity, as indicated by changes in the SUVmax values from the initial scan.

4 completion of the trial

The trial is expected to conclude by June 2025.

Upon completion, final assessments are made to determine the effectiveness of the treatment in reducing sarcoidosis-related inflammation.

Who Can Join the Study?

The patient must have sarcoidosis confirmed by a biopsy. A biopsy is a procedure where a small piece of tissue is taken from the body to be examined under a microscope.
The patient must show inflammatory activity according to an FDG-PET scan at the start of the study. An FDG-PET scan is a type of imaging test that helps doctors see how tissues and organs are functioning.
The patient must have an SUVmax above 3 in the lungs and/or above 5 in the mediastinum/hili. SUVmax is a measurement used in PET scans to show the level of activity in a specific area. The mediastinum is the area in the chest between the lungs, and the hili are the parts of the lungs where blood vessels and nerves enter and leave.
The patient should not have a current need for treatment for sarcoidosis.
Both male and female patients can participate.
The study is open to adults, which typically means individuals aged 18 and older.
The study does not include vulnerable populations, which often refers to groups like children or those unable to give consent.

Who Cannot Join the Study?

Where you can join this trial?

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Site Name	City	Country	Status
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.01.2022

Trial locations

Investigated drugs:

Azithromycin is an antibiotic used in this trial to help reduce inflammation in patients with sarcoidosis. It works by stopping the growth of bacteria that may be contributing to the inflammation.

Doxycycline is another antibiotic included in the trial. It is used alongside azithromycin to target bacteria, specifically C. acnes, which may be present in and around granulomas in sarcoidosis patients. The goal is to see if this combination can significantly decrease inflammatory activity.

Sarcoidosis – Sarcoidosis is a disease characterized by the growth of tiny collections of inflammatory cells, known as granulomas, in different parts of the body, most commonly the lungs and lymph nodes. The exact cause of sarcoidosis is unknown, but it is believed to result from an abnormal immune response. The disease can start suddenly and then disappear, or it can develop gradually and produce symptoms that come and go, sometimes over a lifetime. Common symptoms include fatigue, swollen lymph nodes, and skin rashes. As the disease progresses, it may affect organ function, depending on where the granulomas form. The severity and progression of symptoms can vary widely among individuals.

Trial ID:

2024-513534-38-00

Protocol code:

NL73729.100.21

NCT ID:

NCT05291468

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Azithromycin and Doxycycline for Reducing Inflammation in Sarcoidosis Patients

What is this study about?

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Who Cannot Join the Study?