Not Yet RecruitingPhase 4ACTRN12621000688886

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


Sponsor

Professor Alkis Psaltis

Enrollment

50 participants

Start Date

Sep 1, 2022

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

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 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)

The Queen Elizabeth Hospital - Woodville

SA, Australia

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