Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000808741
Ethics application status
Approved
Date submitted
26/04/2022
Date registered
8/06/2022
Date last updated
10/05/2023
Date data sharing statement initially provided
8/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Dexamethasone in Orbital Cellulitis (DOC) Trial
Scientific title
Efficacy and safety of corticosteroids for orbital cellulitis in adults and children: A randomised controlled trial
Secondary ID [1] 307001 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Orbital cellulitis 326118 0
Pre-septal cellulitis 326119 0
Condition category
Condition code
Eye 323442 323442 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 323445 0
Treatment: Drugs
Comparator / control treatment
The control group will receive standard care for orbital cellulitis/pre-septal cellulitis PLUS a placebo (IV normal saline).

Standard care involves IV antibiotic administration as per the local hospital guidelines +/- surgical drainage at the discretion of the testing clinician depending on whether there is a drainage collection identified and response to antibiotics.
Control group
Placebo

Outcomes
Primary outcome [1] 331179 0
Length of hospitalisation. This week be collected via medical records.
Timepoint [1] 331179 0
0, 1, 2, 3, 10 days and 12 weeks after day of patient’s admission to hospital
Secondary outcome [1] 409098 0
Frequency of surgical interventions
This will be assessed by accessing medical records.
Timepoint [1] 409098 0
0, 1, 2, 3, 10, 30 days and 12 weeks after day of patient’s admission to hospital
Secondary outcome [2] 409841 0
Clinical resolution of periorbital inflammation
Will be assessed by physical examination and graded according to Grading of periorbital inflammation, adapted from El-Sisi et al.
Timepoint [2] 409841 0
0, 1, 2, 3, 10, 30 days and 12 weeks after day of patient’s admission to hospital
Secondary outcome [3] 409842 0
Readmission within the first 30 days of discharge
This will be assessed by accessing medical records.
Timepoint [3] 409842 0
30 days after day of admission
Secondary outcome [4] 409843 0
Incidence of complications (specifically vision loss, ptosis and strabismus).
Will be assessed by physical examination at time points listed below and documented in accordance with CTCAE
Timepoint [4] 409843 0
0, 1, 2, 3, 10, 30 days and 12 weeks after day of patient’s admission to hospital

Eligibility
Key inclusion criteria
Weight at least 5kg
Acute onset (within 14 days) of orbital cellulitis or severe pre-septal cellulitis secondary to any bacterial cause
Minimum age
6 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC

Funding & Sponsors
Funding source category [1] 311313 0
Hospital
Name [1] 311313 0
South Australian Institute of Ophthalmology
Country [1] 311313 0
Australia
Primary sponsor type
Hospital
Name
South Australian Institute of Ophthalmology
Address
Royal Adelaide Hospital
Port Road
Adelaide
South Australia
5000
Country
Australia
Secondary sponsor category [1] 312684 0
None
Name [1] 312684 0
Address [1] 312684 0
Country [1] 312684 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310816 0
Women's and Children's Health Network (WCHN) Human Research Ethics Committee (HREC).
Ethics committee address [1] 310816 0
72 King William Rd, North Adelaide SA 5006
Ethics committee country [1] 310816 0
Australia
Date submitted for ethics approval [1] 310816 0
29/04/2022
Approval date [1] 310816 0
19/10/2022
Ethics approval number [1] 310816 0
2022/HRE00103

Summary
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.?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118962 0
Prof Dinesh Selva
Address 118962 0
Ophthalmology Department
Royal Adelaide Hospital
Port Road
Adelaide
South Australia
5000
Country 118962 0
Australia
Phone 118962 0
+61 08 70742255
Fax 118962 0
Email 118962 0
[email protected]
Contact person for public queries
Name 118963 0
Sonia Huang
Address 118963 0
Ophthalmology Department
Royal Adelaide Hospital
Port Road
Adelaide
South Australia
Adelaide 5000
Country 118963 0
Australia
Phone 118963 0
+61 08 70740000
Fax 118963 0
Email 118963 0
[email protected]
Contact person for scientific queries
Name 118964 0
Sonia Huang
Address 118964 0
Ophthalmology Department
Royal Adelaide Hospital
Port Road
Adelaide
South Australia
5000
Country 118964 0
Australia
Phone 118964 0
+61 08 70740000
Fax 118964 0
Email 118964 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.