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RECRUITING
NCT05157685
PHASE3

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

Sponsor: Centre Hospitalier Intercommunal Creteil

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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