Cellulitis at any body site (excluding orbital or periorbital cellulitis) Skin and Connective Tissue Diseases
Conditions
Interventions
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 r
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.
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain measured using a numerical rating scale (NRS; 0-10) at baseline, and then six timepoints post-randomisation at approximately 12-hour intervals | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health-related quality of life measured using the EQ-5D-5L at Baseline, Day 3, Day 14 and Day 90 post-randomisation 2. Clinical status measured using the Patient Global Impression of Improvement (PGI-I) daily for the first 3 days and at Day 14 post-randomisation 3. Analgesia usage (number and type of analgesia taken over first 3 days) measured using data obtained via a phone call appointment with the participant on Day 14 post-randomisation 4. Antibiotic usage (route, type, and post-randomisation length of course) up to Day 14 measured using data obtained via a phone call appointment with the participant on Day 14 post-randomisation 5. (Re)admissions to the hospital by Day 14 measured using data obtained via a phone call appointment with the participant on Day 14 post-randomisation 6. Complications of dexamethasone use by Day 14 measured using data obtained via a phone call appointment with the participant on Day 14 post-randomisation 7. Unscheduled healthcare usage until Day 14 measured using data recorded on a bespoke healthcare resource use questionnaire on Day 14 post-randomisation 8. Health, social care and broader societal resource use measured using data recorded on a resource use questionnaire based on the Modular Resource Use core module (ModRUM) tailored to the study population at Baseline and Day 90 post-randomisation 9. Recurrence of cellulitis by Day 90 measured using data obtained via a phone call appointment with the participant at Day 90 post-randomisation 10. Serious and/or potentially related adverse events by day 90 measured using data obtained via a phone call appointment with the participant on Day 14 and Day 90 post-randomisation 11. Pain experienced on Day 14 measured using a numerical rating scale (NRS; 0-10) at Day 14 post-randomisation | — |
Countries
England, United Kingdom
Contacts
Public ContactStudy Team
Outcome results
None listed