Dexamethasone as an adjunctive therapy for the management of cellulitis (DEXACELL) - a randomised controlled trial in urgent secondary care
Cellulitis at any body site (excluding orbital or periorbital cellulitis)
Participants will be randomised into the trial by a delegated member of the site team using an online randomisation service. In addition to usual care, trial participants will be randomised on a 1:1 ratio to receive either: • Dexamethasone 8mg orally on recruitment, then dexamethasone 8mg orally ~24 hours later. OR • Matched placebo capsules on recruitment, then matched placebo capsules ~24 hours later. For blinding purposes, the active drug will be over-encapsulated. The participant will take two capsules per dose each capsule containing 1 x 4mg tablet of dexamethasone and backfill. Placebo capsules will be manufactured to match in appearance and will not contain any active ingredients. The capsules used may include bovine gelatin and are HALAL-certified. The active tablets have the following excipients; maize starch, microcrystalline cellulose, lactose monohydrate, highly dispersed silicon dioxide, and magnesium stearate. All capsules will contain a backfill made of one of these excipients.
Current inclusion criteria as of 28/11/2024: 1. Aged 16 years old or over 2. A current clinical diagnosis of cellulitis at any body site except the orbit (periorbital/orbital cellulitis) 3. Able to provide informed consent 4. People of child-bearing potential must be willing to: 4.1. Use a highly effective method of contraception (and must agree to continue 3 months after the last dose of the IMP) 4.2. Inform the trial team if pregnancy occurs during trial participation Previous inclusion criteria: 1. Aged 16 years old or over 2. A current clinical diagnosis of cellulitis at any body site except the orbit (periorbital/orbital cellulitis) 3. Able to provide informed consent 4. People of child-bearing potential must be willing to: 4.1. Use an effective method of contraception (and must agree to continue 3 months after the last dose of the IMP) 4.2. Inform the trial team if pregnancy occurs during trial participation
1. Orbital or periorbital cellulitis, surgical site infection, or planned surgical management (e.g abscess) as managed under a different clinical pathway 2. Allergy to dexamethasone 3. Contraindication to dexamethasone due to concurrent medication (e.g. cobicistat) 4. Has known current invasive fungal infection 5. Has known current gastric or duodenal ulceration 6. Already on corticosteroids - Updated 28/01/2025: Already on systemic corticosteroids 7. Unable to take oral medication 8. Lack of capacity 9. Inability to complete follow-up procedures 10. Prisoner People of child-bearing potential only: 1. Pregnant, breastfeeding, or planning to conceive in next 3 months