Clinical Trial

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

Study acronym: SOPAZITHRO
Recruiting Phase 3
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-12-01; most recent amendment 2025-08-28.
Status change: Not Yet Recruiting → Recruiting 2022-11-28
Trial Details
NCT Number NCT05157685
Lead Sponsor Centre Hospitalier Intercommunal Creteil
Conditions Sinusitis, Chronic, Sinus Infection Chronic
Enrollment 230 participants
Start Date 2022-11-21
Primary Completion 2027-11-21 (estimated)
Study Completion 2027-11-21 (estimated)
Updated on ClinicalTrials.gov 2025-08-29