Phase 3 Chronic Rhinosinusitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 18 and 70 years old
• You have had a sinus condition (chronic rhinosinusitis) lasting more than 12 weeks, affecting both sides of your nose and sinuses, with swelling of the nasal lining and thick, discoloured mucus (confirmed by a camera examination of your nose)
• A scan of your sinuses shows widespread blockage on both sides, including at least the cheek sinuses (maxillary) and the sinuses between and behind the eyes (ethmoids)
• Your sinus infection has not improved despite trying at least 2 courses of antibiotics
• You have signed a consent form agreeing to take part
• You are covered by a health insurance plan

Who may not be able to join:

• You are pregnant or breastfeeding
• Your sinus condition is caused by a known underlying condition, such as an immune deficiency, cystic fibrosis, or HIV
• Your sinus condition does not involve pus (for example, nasal polyps or allergy-related sinusitis)
• Your sinus problem affects only one side, or only one specific sinus
• You have severe liver disease (confirm with trial site)
• You have severe kidney disease (confirm with trial site)
• You have severe heart failure, including specific heart and kidney complications (confirm with trial site)
• You have a documented moderate or significant pre-existing hearing loss in one or both ears
• You have major difficulties with memory or thinking, or you cannot read French well enough to complete questionnaires
• You have a rare inherited condition affecting how your body handles certain sugars (galactose intolerance, lactase deficiency, or glucose-galactose malabsorption)
• You have an allergy to peanuts or soy
• You are allergic to a group of antibiotics called macrolides (e.g. azithromycin, erythromycin)
• You are allergic or intolerant to any ingredient in azithromycin or the dummy (placebo) treatment used in this trial
• You have taken azithromycin in the past 3 months
• You have a heart rhythm problem, an abnormally long electrical signal in your heart (long QT interval), or a slow heart rate (below 60 beats per minute)
• You have low levels of potassium or magnesium in your blood
• You have a suspected or confirmed infection with atypical mycobacteria (a specific type of bacterial infection — confirm with trial site)
• You are taking certain medications that cannot be safely combined with macrolide antibiotics, including some cholesterol medications (atorvastatin, simvastatin), ciclosporin, digoxin, certain heart rhythm drugs, certain antipsychotics, certain antidepressants, certain antibiotics (some fluoroquinolones), ivabradine, colchicine, ergotamine, cisapride, or vitamin K antagonists (confirm with trial site for the full list)
• You are taking medications that lower potassium levels or slow your heart rate
• You have severe bile flow problems (severe cholestasis)
• You are under a legal guardianship arrangement
• You have a blood cancer and have had a stem cell transplant
• You have previously had radiotherapy to your face
• You have a history of cancer in your sinuses or nose
• You are currently taking part in, or have taken part in, another similar clinical trial within the past month

Important: Always verify eligibility with the trial site directly before applying.