Evaluating the additional effect of clarithromycin in the standard of care for non-eosinophilic Chronic Rhinosinusitis patients
A double-blinded randomised control trial evaluating the efficacy of additional long-term low-dose Clarithromycin versus standard of care on post-operative symptomatic outcomes in the treatment of non-eosinophilic Chronic Rhinosinusitis in adults
Professor Alkis Psaltis
50 participants
Sep 1, 2022
Interventional
Conditions
Summary
The purpose of this study is to compare the addition of a low-dose antibiotic with properties that reduce inflammation to the therapy regimen after endoscopic surgery in chronic sinus disease, versus our current standard of care,
Eligibility
Inclusion Criteria9
- Participants who meet ALL the following criteria will be offered inclusion in the study:
- Those who have had symptoms of chronic rhinosinusitis that has been previously persistent for greater than 3 months
- Are over 18 years of age
- Are English speaking
- Can give written informed consent
- Have underwent endoscopic sinus surgery prior
- Have a phenotype of non-eCRS on histological assessment
- Disease control has not been established 6 weeks post-op
- Can commit to return to the clinic for 12- and 18-weeks postoperative endoscopic examination.
Exclusion Criteria7
- Participants who meet one the following criteria will be excluded from the study:
- Allergy to macrolides
- language other than English spoken
- Pregnant or breastfeeding
- History of cardiac disease
- Allergy to steroids
- Covid-19 positive
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Interventions
The intervention will be a Long-Term Low-Dose Clarithromycin administration post endoscopic surgery. If participants meet all inclusion criteria, the intervention will commence 6 weeks post surgery. - the dose: 250mg once daily. - the duration of administration: 3 months. - the mode of administration: oral tablet.
Locations(1)
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ACTRN12621000688886