RecruitingPHASE3INTERVENTIONAL

Evaluation of the Efficacy of Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults

This study is investigating a specific type of long-term sinus infection called Purulent Oedematous Sinusitis (POS) that affects some adults. Many people with POS find their quality of life affected, and current treatments don't always work. The trial aims to see if a common antibiotic, azithromycin (given in a low dose over time), can effectively treat POS. This type of antibiotic is sometimes used for similar conditions when other options have failed, but doctors need more clear evidence to recommend it widely. The study will compare azithromycin to a dummy pill (placebo) to understand if it truly makes a difference for patients whose infections haven't responded to standard care, such as nasal sprays or other antibiotics.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Centre Hospitalier Intercommunal Creteil

Enrolment target

230

Start

21 Nov 2022

Estimated completion

21 Nov 2027

Sinusitis, Chronic Sinus Infection Chronic

What is this study about?

This research is looking into a specific type of long-term (chronic) sinus infection called Purulent Oedematous Sinusitis (POS). It's a condition where the lining of your sinuses becomes swollen and produces pus, and it can be quite bothersome for those who have it regularly. While it's not very common, affecting about 2 out of every 100 people, it can significantly impact how you feel day-to-day, including your work life for many.

Currently, there isn't one best-recommended treatment for this particular type of sinus infection, especially when usual treatments like nasal washes, steroid sprays, or short courses of other antibiotics haven't successfully cleared it up. Some doctors have tried prescribing a common antibiotic called azithromycin, usually at a low dose over a longer time, because it's thought to help with inflammation and fight certain bacteria, even beyond its usual germ-killing effects.

However, using azithromycin this way isn't officially approved for POS, so it's considered 'off-label'. This study aims to provide clear answers: Does this antibiotic truly help people with POS, or is it no better than a dummy pill (placebo)? By carefully studying a specific group of patients with POS, the researchers hope to confirm if azithromycin can become an officially recommended and effective treatment option.

Key takeaways

This study is for adults with a specific, long-lasting sinus infection (POS).
It tests if a common antibiotic, azithromycin, can effectively treat POS.
Participation involves taking tablets daily and attending clinic visits.
The study helps doctors find better treatments for chronic sinus problems.
You might receive the active drug or a dummy pill (placebo).
Your health will be closely monitored throughout the study.

Who may be eligible?

To be considered for this study, you need to be an adult between 18 and 70 years old. You must have a long-lasting sinus infection (Puro-Oedematous Chronic Rhinosinusitis) that has been bothering you for at least 3 months, and standard treatments haven't worked.

Doctors will do specific checks, including a camera look inside your nose and a special scan, to make sure your sinus condition perfectly matches what they are studying. You also can't be pregnant or breastfeeding. It’s important that your specific type of chronic sinusitis is not caused by other known conditions like cystic fibrosis, HIV, or other immune system problems.

Additionally, you can’t have other types of chronic sinus issues like nasal polyps or allergic rhinitis if those are the main problem. Certain serious health conditions like severe liver, kidney, or heart problems, or significant hearing loss, would also mean you couldn't join. You would also need to be able to speak French well enough to complete questionnaires.

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 between 18 and 70 years old?
Have you had chronic sinus problems for at least 3 months that haven't responded to usual treatments?
Are you able to attend appointments and potentially have scans and nasal examinations?
Are you not pregnant or breastfeeding?
Do you speak French well enough to complete questionnaires?
Do you not have severe liver, kidney, or heart conditions or significant hearing loss?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to either take daily low-dose azithromycin tablets or daily dummy (placebo) tablets for a period of time. You won't know which one you're taking, and neither will your G.P. The study involves regular visits to the clinic where doctors will thoroughly check your sinuses, perhaps with a small camera, and you'll likely have follow-up scans. You’ll also be asked to fill out questionnaires about your symptoms and how you are feeling generally. The total duration of your involvement in the study, including all treatments and follow-up assessments, will be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit if the azithromycin treatment proves to be effective for your chronic sinus infection, especially if other treatments haven't worked. However, like all medications, azithromycin can have side effects, and some people may experience mild discomfort from examinations. You will be closely monitored for any issues. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

CHU Bordeaux
Verified postcode
Bordeaux, France· Not yet recruiting
Hôpital Henri Mondor
Verified postcode
Créteil, France· Recruiting
CHU Bicêtre, AP-HP
Verified postcode
Le Kremlin-Bicêtre, France· Recruiting
CHU Lille
Verified postcode
Lille, France· Recruiting
CHU de la Croix Rousse
Verified postcode
Lyon, France· Recruiting
Hospices de Lyon
Verified postcode
Lyon, France· Recruiting
Hôpitaux Universitaires de Marseille Conception
Verified postcode
Marseille, France· Recruiting
CHRU de Nancy
Verified postcode
Nancy, France· Recruiting
Centre Hospitalier Universitaire De Nantes
Verified postcode
Nantes, France· Recruiting
Hôpital Lariboisiere
Verified postcode
Paris, France· Recruiting
CHU Cochin
Verified postcode
Paris, France· Not yet recruiting
CHU Toulouse
Verified postcode
Toulouse, France· Not yet recruiting

Common questions

What is Purulent Oedematous Sinusitis (POS)?

It's a specific type of long-term sinus infection where the sinus lining is swollen and produces pus, causing ongoing symptoms.

What is azithromycin?

It's a common antibiotic that might also help reduce inflammation, which scientists think could be helpful for POS.

Why is this study important?

It's important because there's no clear best treatment for POS when other remedies have failed. This study aims to find out if azithromycin can be a good option.

What is a placebo?

A placebo is a dummy pill that looks like the real medication but contains no active drug. It helps researchers compare the true effects of the medicine.

Can my regular doctor prescribe azithromycin for my chronic sinusitis now?

While some doctors might use it, this study is trying to gather strong evidence to see if it should become a standard treatment for POS specifically. It's currently considered 'off-label' for this use.

How to find out more

Emilie BEQUIGNON

emilie.bequignon@chicreteil.fr 0145175000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.