RecruitingPhase 3NCT05157685

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

Evaluation of the Efficacy of 3-month Continuous Extended Treatment With Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults: a Multicentre Randomised Controlled Trial


Sponsor

Centre Hospitalier Intercommunal Creteil

Enrollment

230 participants

Start Date

Nov 21, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Azithromycin Oral Tablet and a drug called Placebo for people with sinus infection chronic and sinusitis, chronic. The study is currently recruiting participants at 13 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzithromycin 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.

DRUGPlacebo

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

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NCT05157685


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