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Clinical Trial NCT05157685 (SOPAZITHRO) for Sinusitis, Chronic, Sinus Infection Chronic is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Evaluation of the Efficacy of Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults (SOPAZITHRO) Phase 3 230
Evaluation of the Efficacy of 3-month Continuous Extended Treatment With Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults: a Multicentre Randomised Controlled Trial
- SOPAZITHRO
- 2020-001227-13 (EudraCT Number)
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalAzithromycin oral tablet Azithromycin 250 mg once daily morning or evening (with or without meals) | 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 ComparatorPlacebo Placebo once daily morning or evening (with or without meals) | 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. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Comparison of sinonasal outcome test (SNOT) 22 | 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) | 3 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Number of infectious rhinosinus exacerbations | The number of infectious rhinosinus exacerbations during the 3-month period, | 3 months |
Number of courses of antibiotics used | Number of courses of antibiotics used during the 3-month period other than azithromycin or placebo | 3 months |
Visual analog scales of symptoms | Visual analog scales (VAS) of symptoms (self-assessment) (nasal obstruction, rhinorrhea, facial pain, smell disorder, nasal hyperactivity, epistaxis). The VAS measures the intensity of pain on a scale from 0 to 10. | 6 months |
Semi-quantitative symptom scale | Semi-quantitative 4-point symptom scale assessed by the practitioner (min = 0, max = 3) | 6 months |
Semi-quantitative nasal endoscopy score | Semi-quantitative nasal endoscopy score (0: absent/1: present) for each of the following items: presence of pus, edema, erythema, crusts, polyps, scored out of 5 per nasal cavity (maximum score of 10) (Lund Kennedy score), | 6 months |
Quantitative Lund MacKay CT score | Quantitative Lund MacKay CT score (0: no sinus opacity, 1: moderate opacity, 2: total opacity) measured on 12 for each side (score of 24 maximum), | 6 months |
Nasal inflammation flow | Nasal inflammation (nasal nitric oxide (NO) flow, neutrophil polynuclear cell (NPC) and lymphocyte infiltrate on nasal cytology and assays of interleukin 6, 8 and elastase produced by NPCs in nasal secretions) | 6 months |
General quality of life | General quality of life Short form 36 (SF-36) (min=1, max=100) | 6 months |
Days off work | Number of days off work in the 3 months prior to treatment and the number of days off work during the 3 months of treatment | 6 months |
Olfactory score | Olfactory score (sniffing's stick test), | 6 months |
Bacteria present on the protected nasal swab | Identification and quantification of bacteria observed on the protected nasal swab (semi-quantitative score | 6 months |
Number of participants with clinical adverse events as assessed by compliance | Clinical tolerance evaluated by the effective intake of tablets | 3 months |
Number of participants with biological adverse events as assessed by compliance | Biological tolerance evaluated by the effective intake of tablets | 3 months |
Residual effect of the treatment using the SNOT 22 quality of life questionnaires | At 6 months (i.e., 3 months after cessation of treatment), the residual effect of treatment will be measured using the SNOT 22 quality of life questionnaires | 6 months |
Residual effect of the treatment using the SF-36 quality of life questionnaires | At 6 months (i.e., 3 months after cessation of treatment), the residual effect of treatment will be measured using the SF-36 quality of life questionnaires | 6 months |
Residual effect of the treatment using the VAS score | At 6 months (i.e., 3 months after cessation of treatment), the residual effect of treatment will be measured using the VAS score. The VAS measures the intensity of pain on a scale from 0 to 10. | 6 months |
Residual effect of the treatment using the semi-quantitative symptom scale | At 6 months (i.e., 3 months after cessation of treatment), the residual effect of treatment will be measured using the semi-quantitative symptom scale | 6 months |
Residual effect of the treatment using the nasal endoscopy | At 6 months (i.e., 3 months after cessation of treatment), the residual effect of treatment will be measured using the nasal endoscopy | 6 months |
Residual effect of the treatment using the bacteriological samples. | At 6 months (i.e., 3 months after cessation of treatment), the residual effect of treatment will be measured using the bacteriological samples. | 6 months |
Quantitative aspect of the ciliary beat | Quantitative aspect of the ciliary beat (frequency of the beat in Hertz) on a small number of centers having the equipment | 6 months |
Qualitative aspect of the ciliary beat | Qualitative aspect of the ciliary beat (coordination (normal or dyskinetic), index of efficiency)) on a small number of centers having the equipment | 6 months |
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
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
Centre Hospitalier Intercommunal CreteilÎle-de-France Region