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

Study acronym: SOPAZITHRO
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Mar 2025 to Nov 21, 2027v8 Show 4 more changesShow less
    • Study sites: 11 to 13
    • Study completion date: Jun 2025 to Nov 21, 2027
    • Start date: Nov 28, 2022 to Nov 21, 2022
    • Eligibility criteria expanded, about 40 words
  2. Re-verified, no change to tracked fieldsv7
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2022 to Nov 28, 2022
    • Site details revised at 11 of 11 sites
    v6
  4. Start date: May 2022 to Sep 2022v5
  5. Eligibility criteria expanded, about 168 wordsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Mar 2022 to May 2022
    • Primary completion date: Jan 2025 to Mar 2025
    • Study completion date: Apr 2025 to Jun 2025
    v3
  2. Start date: Dec 2021 to Mar 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05157685
Lead Sponsor Centre Hospitalier Intercommunal Creteil
Conditions
(from sponsor)		 Sinusitis, Chronic, Sinus Infection Chronic
Related terms Bronchiolitis Obliterans Syndrome, Sinusitis
Enrollment 230 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov