Dexamethasone in Orbital Cellulitis (DOC) Trial
Efficacy and safety of corticosteroids for orbital cellulitis in adults and children: A randomised controlled trial
South Australian Institute of Ophthalmology
128 participants
May 15, 2023
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
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
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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.
Locations(1)
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ACTRN12622000808741