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Evaluation of the Efficacy of 3-month Continuous Extended Treatment With Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults: a Multicentre Randomised Controlled Trial
EU CTIS ID: 2024-517239-33-00
What this study is testing
The evolution (intra-individual difference) of the specific quality of life score (Sino-Nasal Outcome Test 22 : SNOT 22) between inclusion and the end of 3 months of treatment.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- Rebellious form of persistent purulent rhinosinusitis despite at least 2 antibiotic therapies prescribed according to HAS recommendations in force for ethmoid sinusitis
- Signed informed consent of the patient
- Membership in a health insurance plan or beneficiary
You likely can't join if
- Pregnancy or breastfeeding
- 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
See the full eligibility criteria
Who can join
- 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
- Rebellious form of persistent purulent rhinosinusitis despite at least 2 antibiotic therapies prescribed according to HAS recommendations in force for ethmoid sinusitis
- Signed informed consent of the patient
- Membership in a health insurance plan or beneficiary
What rules you out
- Pregnancy or breastfeeding
- 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)
- 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 drug
- PCOS of identified primary cause (identified immune deficiency, cystic fibrosis)
- Patients with severe cholestasi
- Patients under guardianship or curatorsh
- 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
- 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 hearing loss (>30dB) or single ear (unilateral cophosis)
- Major cognitive impairment or lack of French language skills preventing completion of SNOT-22 and SF-36 questionnaires
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.