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Recruiting Phase 3

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

NCT05157685 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2022-11-21
Last updated
2025-08-29

Condition(s) studied

Sinusitis, ChronicSinus Infection Chronic

Investigational drug(s) / intervention(s)

Azithromycin Oral Tablet →Placebo

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Patient older than 18 years and less than 70 years of age * Chronic rhinosinusitis (\> 12 weeks of evolution) meeting the definition published in the European Paper Position2012 (1) and corresponding exclusively to the following endoscopic and CT criteria: * Nasal endoscopy showing bilateral and diffuse involvement associating edema of the mucosa of the nasal cavities and meatus with the presence of mucopurulent secretions in these areas * Nasosinus CT scan showing diffuse and bilateral pansinus opacities involving at least the maxillary sinuses and the anterior and posterior ethmoids * Persistent intractable purulent rhinosinusitis despite at least 2 antibiotic therapies * Signed informed consent of the patient * Membership in a health insurance plan or beneficiary Exclusion Criteria: * Pregnancy or breastfeeding * PCOS of identified primary cause (identified immune deficiency, cystic fibrosis, HIV) * Chronic non-purulent rhinosinusitis (nasosinusal polyposis, allergic rhinosinusitis) * Localized chronic suppurative rhinosinusitis (single sinus, unilateral, frontal or maxillary or sphenoidal) * Severe hepatic insufficiency (factor V level \< 50%) * Severe renal insufficiency (stage 4 (GFR \< 30 ml/min/1.73 m2) and/or creatinine \< 40 ml/min) * Severe heart failure (old age, ischemic heart disease, episode of recurrent cardiac arrest; hypotension, NYHA functional stage III-IV; widened QRS, complex ventricular arrhythmias; hyponatremia (Na \<135mmol/l); stage 4 renal failure (GFR \< 30 ml/min/1.73 m2); severely depressed LVEF (\< 30%) * Documented moderate pre-existing sensorineural hearing loss with a mean pure tone threshold in the poorer ear in bone conduction \>30 dB across all 3 frequencies (500, 1000 and 2000 Hz) or in only one ear (unilateral deafness). * Major cognitive impairment or lack of French language skills preventing completion of SNOT-22 and SF-36 questionnaires * Patient with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases) * Patient with peanut or soy allergy * Patient allergic to macrolides * Patients who are intolerant or allergic to any of the excipients of azithromycin or placebo * Treatment with azithromycin in the previous 3 months * Long QT on ECG ((\>440ms for male and \>450ms for female) or cardiac arrhythmia or bradycardia (\<60btm).The calculation of the corrected QT should be carried out using the Bazett formula. * Hypokalemia or hypomagnesemia on blood ionogram * Confirmed or suspected atypical mycobacteriosis * Contraindicated drug combinations with macrolides (K-vitamins or drugs containing cisapride, colchicine, ergotamine or dihydroergotamine) * Cautionary drug combinations (non-inclusion criteria) * Atorvastatin (Increased risk of concentration-dependent rhabdomyolysis-type adverse events due to decreased hepatic metabolism of the cholesterol-lowering drug. * Ciclosporin (risk of increased ciclosporin blood levels and creatinine levels) * Digoxin (increase in digoxemia due to increased absorption of digoxin), Drugs likely to cause torsades de pointes, in particular class IA (e.g. quinidine) and class III (e.g. amiodarone, sotalol) antiarrhythmics, antipsychotics (e.g. phenothiazines, pimozide), tricyclic antidepressants (e.g. citalopram), certain fluoroquinolones (e.g. moxifloxacin, levofloxacin) (increased risk of ventricular rhythm disturbances) * Simvastatin (increased risk of rhabdomyolysis-type adverse effects (concentration-dependent), due to decreased hepatic metabolism of the cholesterol-lowering agent) * Ivabradine (increased risk of ventricular rhythm disorders), * Hypokalemic drugs * Bradycardia drugs * Patients with severe cholestasis * Patients under guardianship or curatorship * Patients with hematologic malignancies who have undergone hematopoietic stem cell transplantation * History of facial radiotherapy * History of rhinosinus cancer * Participation in other category 1 research at the time of inclusion or in the month prior to inclusion

Primary outcome measure(s)

  • Comparison of sinonasal outcome test (SNOT) 22 — 3 months
    Comparison of the means of the Sinonasal Outcome Test (SNOT 22) specific quality of life scores after 3 months of treatment. (min = 0, max = 110)

Trial sites (13)

FacilityCityRegionStatus
CHU Bordeaux Bordeaux France Not Yet Recruiting
Hôpital Henri Mondor Créteil France Recruiting
CHU Bicêtre, AP-HP Le Kremlin-Bicêtre France Recruiting
CHU Lille Lille France Recruiting
CHU de la Croix Rousse Lyon France Recruiting
Hospices de Lyon Lyon France Recruiting
Hôpitaux Universitaires de Marseille Conception Marseille France Recruiting
CHRU de Nancy Nancy France Recruiting
Centre Hospitalier Universitaire De Nantes Nantes France Recruiting
Hôpital Lariboisiere Paris France Recruiting
CHU Cochin Paris France Not Yet Recruiting
CHU Toulouse Toulouse France Not Yet Recruiting
Centre Hospitalier Intercommunal Créteil Île-de-France Region Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05157685 on ClinicalTrials.gov ↗ ← All trials in France