Ongoing, recruitingTherapeutic use (Phase IV)Interventional

The PHENOSAR trial: Antibiotic treatment of biopsy confirmed phenotypes in sarcoidosis: a proof of concept clinical trial.

This study, called PHENOSAR, is exploring a new way to treat sarcoidosis, a condition that causes small lumps of inflammatory cells to grow in different parts of the body. We are looking at whether two common antibiotic medications, Doxiclat (100mg) and Azithran (500mg), can help reduce the inflammation linked to sarcoidosis. This is a "proof of concept" study, meaning we are testing if these existing treatments could have benefits for sarcoidosis patients when targeted to specific types of the disease. It's a Phase IV study, which means these drugs are already approved for other uses, but we're investigating a new potential use for sarcoidosis. Anyone aged 18 or over, regardless of gender, may be considered for participation.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Sint Antonius Ziekenhuis Stichting

Enrolment target

Start

13 May 2024

sarcoidosis

What is this study about?

This study, called PHENOSAR, is trying to find out if certain types of antibiotics, Doxiclat and Azithran, can help people who have sarcoidosis. Sarcoidosis is a condition where tiny clumps of cells, called granulomas, can grow in different organs of your body, most commonly the lungs, skin, or eyes. These clumps can cause inflammation and affect how your organs work.

We know that some antibiotics have properties that can help reduce inflammation, not just fight infections. In this study, we're looking to see if these specific antibiotics can help calm down the inflammation seen in sarcoidosis. This approach is called a "proof of concept" trial because we're testing a new idea – to see if existing and well-known medicines can be repurposed to help with sarcoidosis. If successful, it could offer a new treatment option for patients.

This is a Phase IV trial. This means that Doxiclat and Azithran are already approved medicines used for other conditions. We are not testing entirely new drugs, but rather exploring if these established medicines can be beneficial for people with sarcoidosis. The main goal is to see if they can reduce the inflammation caused by the condition.

Key takeaways

This study explores if antibiotics can reduce sarcoidosis inflammation.
It uses existing medicines, Doxiclat and Azithran.
The goal is to find new ways to manage sarcoidosis.
Open to adults aged 18 and over with confirmed sarcoidosis.
Regular clinic visits and close monitoring will be involved.

Who may be eligible?

To join this study, we are looking for adults aged 18 and over. Your gender does not matter – both men and women can take part.

However, it's very important that you have a confirmed diagnosis of sarcoidosis. This means a doctor would have taken a small sample (a biopsy) from one of the affected areas of your body to confirm you have the condition. The study is specifically looking at different types of sarcoidosis, which your doctor will be able to explain further.

Many other factors will also determine if you can join, such as other health conditions you might have, or other medications you are currently taking. Your study doctor and research team will carefully review your medical history to ensure the study is safe and appropriate for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with sarcoidosis by a biopsy?
Are you able to attend regular clinic appointments?
Are you willing to take study medication as prescribed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the clinic. These visits will typically involve physical examinations, blood tests, and possibly other tests like scans to monitor your sarcoidosis and how your body is responding to the treatment. You will be given either Doxiclat (100mg tablets) or Azithran (500mg tablets) to take as prescribed.

The research team will provide you with detailed instructions on how and when to take your medication. They will also keep a close eye on you for any side effects or changes in your condition. The total duration of your participation, including follow-up appointments after you finish taking the medication, will be explained fully by the study team before you agree to join.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a potential new treatment for your sarcoidosis and closely monitored care from specialists. However, there's no guarantee that the treatment will be helpful for you. As with any medication, Doxiclat and Azithran can have side effects, which will be fully explained by the research team. You will have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is sarcoidosis?

Sarcoidosis is a condition where your immune system causes small clumps of inflammatory cells, called granulomas, to grow in organs like your lungs, skin, or eyes. It can cause inflammation and affect how these organs work.

What are Doxiclat and Azithran?

These are both antibiotics commonly used to treat infections. In this study, we're investigating if they can also help reduce the inflammation caused by sarcoidosis, not just fight bacteria.