Not Yet RecruitingPhase 4ACTRN12622000808741

Dexamethasone in Orbital Cellulitis (DOC) Trial

Efficacy and safety of corticosteroids for orbital cellulitis in adults and children: A randomised controlled trial


Sponsor

South Australian Institute of Ophthalmology

Enrollment

128 participants

Start Date

May 15, 2023

Study Type

Interventional

Conditions

Summary

Orbital cellulitis is a serious infection that can lead to permanent vision loss and death. Pre-septal cellulitis refers to infection that remains in front of the orbital septum, which can be clinically indistinguishable from orbital cellulitis when severe. Current treatment options for these conditions include intravenous antibiotics and surgical drainage. Although these methods are effective, inflammation can often persist for weeks to months. The use of steroids in orbital cellulitis is controversial and practices vary widely. The literature around this remains minimal and there are currently no studies to determine the role of corticosteroids in severe pre-septal cellulitis. We aim to conduct the first comprehensive randomised controlled trial to evaluate the role of corticosteroids in the management of orbital cellulitis and severe preseptal cellulitis. This study will be significant in informing future clinical practice by providing a standardised corticosteroid treatment protocol. Each enrolled participant will be randomised to receive either steroid or placebo and will be required to be followed up for 12 weeks after their initial admission to hospital.?


Eligibility

Sex: Both males and femalesMin Age: 6 Monthss

Inclusion Criteria2

  • Weight at least 5kg
  • Acute onset (within 14 days) of orbital cellulitis or severe pre-septal cellulitis secondary to any bacterial cause

Exclusion Criteria6

  • Concomitant intracranial complications
  • Sepsis
  • Systemic immunosuppression
  • Suspected non-bacterial cause of orbital cellulitis, including fungal or tubercular infections
  • Treatment with systemic corticosteroids prior to admission
  • Dexamethasone allergy

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Intravenous (IV) Dexamethasone 0.15mg/kg, once daily for 3 days started at time of admission. Adherence will be monitored by checking medical records that the mediation was delivered.

Intravenous (IV) Dexamethasone 0.15mg/kg, once daily for 3 days started at time of admission. Adherence will be monitored by checking medical records that the mediation was delivered.


Locations(1)

NSW,SA,VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12622000808741


Related Trials