Actively Recruiting
Evaluation of the Efficacy of Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults
Led by Centre Hospitalier Intercommunal Creteil · Updated on 2025-08-29
230
Participants Needed
13
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Purulent Oedematous Sinusitis (POS) is a particular form of chronic rhinosinusitis observed in 2% of the general population. In spite of its heavy impact on the quality of life, There is no established recommendation for the treatment of primary POS. Long-term low-dose macrolides are currently proposed for these forms of chronic rhinosinusitis when conventional treatments (local corticosteroids, saline rinsing, iterative short courses of antibiotics targeted on pathogens, and surgical opening and drainage) have failed. This treatment with macrolides is currently applied off-label. This study aims to assess the efficacy of macrolides in POS. An extensive workup is fulfilled to exclude other forms of chronic rhinosinusitis (Th2 biased inflammatory diseases, allergic diseases) (allergy, nasosinusal polyposis) or those due to cystic fibrosis or immune deficiency.
CONDITIONS
Official Title
Evaluation of the Efficacy of Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient older than 18 years and less than 70 years of age
- Chronic rhinosinusitis lasting more than 12 weeks with bilateral mucosal edema and mucopurulent secretions seen on nasal endoscopy
- CT scan showing diffuse and bilateral sinus opacities involving maxillary sinuses and ethmoids
- Persistent purulent rhinosinusitis despite at least two antibiotic treatments
- Signed informed consent
- Membership in a health insurance plan or beneficiary
You will not qualify if you...
- Pregnancy or breastfeeding
- Known primary cause of POS such as immune deficiency, cystic fibrosis, or HIV
- Chronic non-purulent rhinosinusitis including nasal polyposis or allergic rhinosinusitis
- Localized suppurative rhinosinusitis affecting a single sinus
- Severe liver failure (factor V < 50%)
- Severe kidney failure (stage 4, GFR < 30 ml/min/1.73 m2)
- Severe heart failure or significant cardiac conditions
- Moderate pre-existing sensorineural hearing loss
- Major cognitive impairment or inability to complete questionnaires
- Rare hereditary metabolic diseases (galactose intolerance, lactase deficiency, glucose-galactose malabsorption)
- Allergy to macrolides or excipients in study drugs
- Azithromycin treatment within the past 3 months
- Prolonged QT interval or cardiac arrhythmias
- Low potassium or magnesium levels
- Atypical mycobacteriosis
- Contraindicated or cautionary drug combinations with macrolides
- Severe cholestasis
- Legal guardianship or curatorship
- Hematologic malignancy with stem cell transplant
- History of facial radiotherapy or rhinosinus cancer
- Participation in other category 1 research recently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
CHU Bordeaux
Bordeaux, France
Not Yet Recruiting
2
Hôpital Henri Mondor
Créteil, France, 94010
Actively Recruiting
3
CHU Bicêtre, AP-HP
Le Kremlin-Bicêtre, France
Actively Recruiting
4
CHU Lille
Lille, France, 59000
Actively Recruiting
5
CHU de la Croix Rousse
Lyon, France
Actively Recruiting
6
Hospices de Lyon
Lyon, France
Actively Recruiting
7
Hôpitaux Universitaires de Marseille Conception
Marseille, France, 13005
Actively Recruiting
8
CHRU de Nancy
Nancy, France
Actively Recruiting
9
Centre Hospitalier Universitaire De Nantes
Nantes, France, 44093
Actively Recruiting
10
Hôpital Lariboisiere
Paris, France, 75010
Actively Recruiting
11
CHU Cochin
Paris, France
Not Yet Recruiting
12
CHU Toulouse
Toulouse, France
Not Yet Recruiting
13
Centre Hospitalier Intercommunal
Créteil, Île-de-France Region, France, 94000
Actively Recruiting
Research Team
E
Emilie BEQUIGNON
CONTACT
C
Camille JUNG
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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