Dexamethasone in Orbital Cellulitis (DOC) Trial

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622000808741

Enrollment

128

Registered

2022-06-08

Start date

2023-05-15

Completion date

Unknown

Last updated

2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.?

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.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

6 Months to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Outcome results