NCT07345819

Brief Summary

The goal of this pilot randomized controlled trial is to understand whether we can successfully conduct a larger definitive clinical trial in the future. The current pilot study will test various aspects of the larger trial and help us improve its design if needed. The investigators are mainly interested in knowing whether they can (1) recruit enough patients, (2) administer the intervention, and (3) collect all the data needed from patients. The definitive randomized controlled trial will assess if dexamethasone is superior to placebo for treating children and youth hospitalized with orbital cellulitis.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Apr 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

January 6, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

January 6, 2026

Last Update Submit

January 16, 2026

Conditions

Orbital Cellulitis

Keywords

orbital cellulitispilot trialpilot RCTpreseptal cellulitisperiorbital cellulitisdexamethasonecorticosteroidinpatientRCTrandomized controlled trialpediatricpaediatricchildrenyouth

Outcome Measures

Primary Outcomes (1)

  • Recruitment rate

    Recruitment rate is measured as the number of patients agreeing to participate in the trial and are randomized, divided by the number of patients screened as eligible at 18 months after initiation of the trial recruitment (per site).

    From start of recruitment to end of recruitment (anticipated 18 months).

Secondary Outcomes (2)

  • Intervention fidelity

    96 hours after the patient is admitted to hospital.

  • Completion of definitive trial primary and secondary outcomes

    Three months after the patient is discharged from hospital.

Study Arms (2)

Intervention

EXPERIMENTAL

Dexamethasone 0.3 mg/kg (max dose 12 mg) IV after randomization, and a second dose 24 hours (+/-8 hours) after the first dose

Drug: Dexamethasone 0.3mg/kg

Placebo

PLACEBO COMPARATOR

Sodium Chloride 0.9% IV after randomization and second dose 24 hours (+/- 8 hours) after the first dose

Drug: Placebo Control

Interventions

Dexamethasone 0.3mg/kgDRUG

SANDOZ-DEXAMETHASONE SODIUM PHOSPHATE INJ USP 4MG/ML (5 mL vial) (DIN# 00664227) or any brand available commercially in the Canadian market. Dexamethasone 0.3 mg/kg (max dose 12 mg) will be given by IV after randomization. The second dose will be given 24 hours (+/-8 hours) after the first dose. The most recent weight recorded in the patient's chart will be used for the dose calculation.

Intervention
Placebo ControlDRUG

Sodium Chloride 0.9% Injection USP Placebo Baxter brand (or any commercially available in the Canadian market) given by IV, first dose administered after randomization and second dose 24 hours (+/- 8 hours) after the first.

Placebo

Eligibility Criteria

Age2 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 2.00 months -17.99 years (prior to 18th birthday)
  • Confirmed or suspected diagnosis of orbital cellulitis as determined by the attending physician, medical team, and/or delegate's clinical judgement, based on one or more features of orbital cellulitis (i.e., ophthalmoplegia, pain and/or limitation with extraocular movements, chemosis, blurred vision, eye swollen shut, and/or proptosis).
  • Scheduled to be admitted or admitted to hospital for less than 36 hours.
  • Informed consent provided in accordance with institutional policies

You may not qualify if:

  • Transferred directly from outside hospital inpatient setting to a participating hospital site's inpatient setting with over 36 hours having passed since admission to outside hospital. If within 36 hours, patient is eligible.
  • Treatment with IV or PO systemic corticosteroids within 1 week of presentation
  • Recent hospital admission for orbital cellulitis within 1 week of presentation
  • Current systemic fungal infection
  • Contraindication for dexamethasone or components of dexamethasone IV formulation
  • Clinically relevant varicella exposure in the previous 21 days
  • Previous enrollment in this study
  • No telephone/mobile/email
  • Poor mastery of English, or medical interpreter not available for languages other than English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Stollery Children's Hospital

Edmonton, T6G 2B7, Canada

Location

Related Publications (3)

  • Gonsalves CL, Borkhoff C, Mahant S, Drouin O, Pound C, Quet J, Wahi G, Bayliss A, Vomiero G, Foulds JL, Kanani R, Sakran M, Sehgal A, Pullenayegum E, Widjaja E, Reginald A, Wolter NE, Parkin PC, Gill PJ; Periorbital and Orbital Cellulitis (POC) Multicentre Study Group and Canadian Paediatric Inpatient Research Network (PIRN). Association of systemic corticosteroids and clinical outcomes in children hospitalised with severe orbital infections. BMJ Paediatr Open. 2025 Dec 11;9(1):e004161. doi: 10.1136/bmjpo-2025-004161.

    PMID: 41381246BACKGROUND

  • Kornelsen E, Mahant S, Parkin P, Ren LY, Reginald YA, Shah SS, Gill PJ. Corticosteroids for periorbital and orbital cellulitis. Cochrane Database Syst Rev. 2021 Apr 28;4(4):CD013535. doi: 10.1002/14651858.CD013535.pub2.

    PMID: 33908631BACKGROUND

  • Gill PJ, Mahant S, Hall M, Parkin PC, Shah SS, Wolter NE, Mestre M, Markham JL. Association Between Corticosteroids and Outcomes in Children Hospitalized With Orbital Cellulitis. Hosp Pediatr. 2022 Jan 1;12(1):70-89. doi: 10.1542/hpeds.2021-005910.

    PMID: 34877598BACKGROUND

MeSH Terms

Conditions

Orbital Cellulitis

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Orbital DiseasesEye DiseasesCellulitisConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Peter J Gill, MD, DPhil

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter J Gill, MD, DPhil

CONTACT

416-813-7654peter.gill@sickkids.ca

Anmol Samra, MPH, BSc

CONTACT

anmol.samra@sickkids.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Paediatrician and Senior Scientist

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 16, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)