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Evaluation of the Efficacy of Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults
Sponsor: Centre Hospitalier Intercommunal Creteil
Summary
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.
Official title: Evaluation of the Efficacy of 3-month Continuous Extended Treatment With Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults: a Multicentre Randomised Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
230
Start Date
2022-11-21
Completion Date
2027-11-21
Last Updated
2025-08-29
Healthy Volunteers
No
Interventions
Azithromycin Oral Tablet
Treatment assigned by randomization will be prescribed immediately. The active or placebo will be dispensed by the centre's pharmacy. Treatment will be taken in the morning or evening for 3 months.
Placebo
Treatment assigned by randomization will be prescribed immediately. The active or placebo will be dispensed by the centre's pharmacy. Treatment will be taken in the morning or evening for 3 months.
Locations (13)
CHU Bordeaux
Bordeaux, France
Hôpital Henri Mondor
Créteil, France
CHU Bicêtre, AP-HP
Le Kremlin-Bicêtre, France
CHU Lille
Lille, France
CHU de la Croix Rousse
Lyon, France
Hospices de Lyon
Lyon, France
Hôpitaux Universitaires de Marseille Conception
Marseille, France
CHRU de Nancy
Nancy, France
Centre Hospitalier Universitaire De Nantes
Nantes, France
Hôpital Lariboisiere
Paris, France
CHU Cochin
Paris, France
CHU Toulouse
Toulouse, France
Centre Hospitalier Intercommunal
Créteil, Île-de-France Region, France