AZITHROMYCIN for Chronic rhinosinusitis | Bacterial sinusitis

Inclusion criteria

• {"criterion_text":"- Patient older than 18 years and less than 70 years of age\n- 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\n- Rebellious form of persistent purulent rhinosinusitis despite at least 2 antibiotic therapies prescribed according to HAS recommendations in force for ethmoid sinusitis\n- Signed informed consent of the patient\n- Membership in a health insurance plan or beneficiary"}

Exclusion criteria

• {"criterion_text":"- Pregnancy or breastfeeding\n- PCOS of identified primary cause (identified immune deficiency, cystic fibrosis)\n- Chronic non-purulent rhinosinusitis (nasosinusal polyposis, allergic rhinosinusitis)\n- Localized chronic suppurative rhinosinusitis (single sinus, unilateral, frontal or maxillary or sphenoidal)\n- Severe hepatic insufficiency (factor V level < 50%)\n- Severe renal insufficiency (stage 4 (GFR < 30 ml/min/1.73 m2) and/or creatinine < 40 ml/min)\n- 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%)\n- Documented moderate pre-existing hearing loss (>30dB) or single ear (unilateral cophosis)\n- Major cognitive impairment or lack of French language skills preventing completion of SNOT-22 and SF-36 questionnaires\n- Patient with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases)\n- Patient with peanut or soy allergy\n- Patient allergic to macrolides\n- Patients who are intolerant or allergic to any of the excipients of azithromycin or placebo\n- Treatment with azithromycin in the previous 3 months\n- Long QT on ECG ((>440ms for male and >450ms for female) or cardiac arrhythmia or bradycardia (<60btm)\n- Hypokalemia or hypomagnesemia on blood ionogram\n- Confirmed or suspected atypical mycobacteriosis\n- Contraindicated drug combinations with macrolides (K-vitamins or drugs containing cisapride, colchicine, ergotamine or dihydroergotamine\n- 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\n- Patients with severe cholestasi\n- Patients under guardianship or curatorsh\n- Patients with hematologic malignancies who have undergone hematopoietic stem cell transplantation\n- History of facial radiotherapy\n- History of rhinosinus cancer\n- Participation in other category 1 research at the time of inclusion or in the month prior to inclusion"}

Primary endpoints

• {"endpoint_text":"- Comparison of sinonasal outcome test (SNOT) 22 specific quality of life score averages","definition_or_measurement_approach":"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."}

Secondary endpoints

• {"endpoint_text":"- Number of infectious rhinosinus exacerbations","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of courses of antibiotics use","definition_or_measurement_approach":""}
• {"endpoint_text":"- Visual analog scales of symptoms","definition_or_measurement_approach":""}
• {"endpoint_text":"- Semi-quantitative symptom scale","definition_or_measurement_approach":""}
• {"endpoint_text":"- Semi-quantitative nasal endoscopy score","definition_or_measurement_approach":""}
• {"endpoint_text":"- Quantitative Lund MacKay CT score","definition_or_measurement_approach":""}
• {"endpoint_text":"- Nasal inflammation flow","definition_or_measurement_approach":""}
• {"endpoint_text":"- General quality of life Short form-36 (SF-36)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Days off work","definition_or_measurement_approach":""}
• {"endpoint_text":"- Olfactory score","definition_or_measurement_approach":""}
• {"endpoint_text":"- Bacteria present on the protected nasal swab","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of participants with clinical adverse events as assessed by compliance","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of participants with biological adverse events as assessed by compliance","definition_or_measurement_approach":""}
• {"endpoint_text":"- Residual effect of the treatment using the SNOT 22 quality of life questionnaire","definition_or_measurement_approach":""}
• {"endpoint_text":"- Residual effect of the treatment using the SF-36 quality of life questionnaires","definition_or_measurement_approach":""}
• {"endpoint_text":"- Residual effect of the treatment using the VAS score","definition_or_measurement_approach":""}
• {"endpoint_text":"- Residual effect of the treatment using the semi-quantitative symptom scale","definition_or_measurement_approach":""}
• {"endpoint_text":"- Residual effect of the treatment using the nasal endoscopy","definition_or_measurement_approach":""}
• {"endpoint_text":"- Residual effect of the treatment using the bacteriological samples.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Quantitative aspect of the ciliary beat","definition_or_measurement_approach":""}
• {"endpoint_text":"- Qualitative aspect of the ciliary beat","definition_or_measurement_approach":""}

France

Earliest CTIS Part Ii Submission Date

11-10-2024

Latest Decision Or Authorization Date

18-08-2025

Processing Time Days

311

Number Of Sites

13

Number Of Participants

244

Primary sponsor

Full Name

Centre Hospitalier Intercommunal Creteil

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France